Tolnaftate

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Tolnaftate Recall

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Side Effects & Adverse Reactions

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

When using this product avoid contact with eyes

Stop use and ask a doctor if

irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
irritation occurs or if there is no improvement within 2 weeks (for jock itch)

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Do not use

on children under 2 years of age unless directed by a doctor

When using this product avoid contact with eyes

Stop use and ask a doctor if

irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
irritation occurs or if there is no improvement within 2 weeks (for jock itch)

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
for effective relief of itchy, scaly skin between the toes
clears up most athlete's foot infection and with daily use helps keep it from coming back

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

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Tolnaftate Manufacturers

A-s Medication Solutions Llc

Tolnaftate | A-s Medication Solutions Llc

clean the affected area and dry thoroughly apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product
For athlete's foot
use daily for 4 weeks. If condition persists longer, consult a doctor pay special attention to the spaces between the toes wear well fitting ventilated shoes change shoes and socks at least once daily
For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

No Recall
Topco Associates Llc

Tolnaftate | Topco Associates Llc

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product use daily for 2 weeks; if conditions persist, consult a doctor in case of clogging, clear nozzle under running water

No Recall
Topco Associates Llc

Tolnaftate | Topco Associates Llc

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks if conditions persist, consult a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) in case of clogging, clear nozzle under running water

No Recall
Topco Associates Llc

Tolnaftate | Topco Associates Llc

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks if conditions persist, consult a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails

No Recall
Topco Associates Llc

Tolnaftate | Topco Associates Llc

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks for athletes foot, ringworm and for jock itch use daily for 2 weeks if conditions persist, consult a doctor to prevent athlete's foot, apply daily once or twice daily (morning and/or night) this product is not effective on the scalps or nails in case of clogging, clear nozzle under running water

No Recall
Premier Value

Tolnaftate | Chain Drug Consortium, Llc

wash affected area and dry thoroughly if necessary, cut medicated patch to fit callus apply adhesive side down of medicated patch onto callus cover medicated patch with pad after 48 hours, remove medicated patch repeat procedure every 48 hours as needed for up to 14 days (until callus is removed) may soak callus in warm water for 5 minutes to assist in removal

No Recall
Premier Value

Tolnaftate | Chain Drug Consortium, Llc

shake can well adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily to apply to face spray in palm of hand and gently apply for children under 2 years of age, ask a doctor

No Recall
Premier Value

Tolnaftate | Kinray

• take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over

30 mL (2 TBSP) every 4 hrs

children 6 to under 12 yrs

15 mL (1 TBSP) every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use
Other information • each 15 mL contains: sodium 6 mg • store at 20-25 °C (68-77 °F). Do not refrigerate.

No Recall
Premier Value

Tolnaftate | Mallinckrodt Nuclear Medicine Llc

For Myocardial Imaging: The suggested dose range for I.V. administration of Technetium Tc 99m Sestamibi in a single dose to be employed in the average patient (70 Kg) is 370–1110 MBq (10–30 mCi).

For Breast Imaging: The recommended dose range for I.V. administration of Technetium Tc 99m Sestamibi is a single dose of 740–1110 MBq (20–30 mCi).
2.1 Image Acquisition
Breast Imaging: It is recommended that images are obtained with a table overlay to separate breast tissue from the myocardium and liver, and to exclude potential activity that may be present in the opposite breast. For lateral images, position the patient prone with the isolateral arm comfortably above the head, shoulders flat against the table, head turned to the side and relaxed, with the breast imaged pendent through an overlay cutout. The breast should not be compressed on the overlay. For anterior images, position the patient supine with both arms behind the head. For either lateral or anterior images, shield the chest and abdominal organs, or remove them from the field of view.

For complete study, sets of images should be obtained five minutes after the injection, and in the following sequence:

Beginning five minutes after the injection of Technetium Tc 99m Sestamibi:
ten-minute lateral image of breast with abnormality ten-minute lateral image of contralateral breast ten-minute anterior image of both breasts 2.2 Radiation Dosimetry
The radiation doses to organs and tissues of an average patient (70 Kg) per 1110 MBq (30 mCi) of Technetium Tc 99m Sestamibi injected intravenously are shown in Table 1.
Table 1. Radiation Absorbed Doses from Tc 99m Sestamibi
Radiation dosimetry calculations performed by Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, PO Box 117, Oak Ridge, TN 37831-0117, (865) 576-3448.
Estimated Radiation Absorbed Dose REST 2.0 hour void 4.8 hour void Organ rads/30 mCi mGy/1110 MBq rads/30 mCi mGy/1110 MBq Breasts 0.2 2.0 0.2 1.9 Gallbladder Wall 2.0 20.0 2.0 20.0 Small Intestine 3.0 30.0 3.0 30.0 Upper Large
Intestine Wall 5.4 55.5 5.4 55.5 Lower Large
Intestine Wall 3.9 40.0 4.2 41.1 Stomach Wall 0.6 6.1 0.6 5.8 Heart Wall 0.5 5.1 0.5 4.9 Kidneys 2.0 20.0 2.0 20.0 Liver 0.6 5.8 0.6 5.7 Lungs 0.3 2.8 0.3 2.7 Bone Surfaces 0.7 6.8 0.7 6.4 Thyroid 0.7 7.0 0.7 2.4 Ovaries 1.5 15.5 1.6 15.5 Testes 0.3 3.4 0.4 3.9 Red Marrow 0.5 5.1 0.5 5.0 Urinary Bladder Wall 2.0 20.0 4.2 41.1 Total Body 0.5 4.8 0.5 4.8 Estimated Radiation Absorbed Dose STRESS 2.0 hour void 4.8 hour void Organ rads/30 mCi mGy/1110 MBq rads/30 mCi mGy/1110 MBq Breasts 0.2 2.0 0.2 1.8 Gallbladder Wall 2.8 28.9 2.8 27.8 Small Intestine 2.4 24.4 2.4 24.4 Upper Large
Intestine Wall 4.5 44.4 4.5 44.4 Lower Large
Intestine Wall 3.3 32.2 3.3 32.2 Stomach Wall 0.6 5.3 0.5 5.2 Heart Wall 0.5 5.6 0.5 5.3 Kidneys 1.7 16.7 1.7 16.7 Liver 0.4 4.2 0.4 4.1 Lungs 0.3 2.6 0.2 2.4 Bone Surfaces 0.6 6.2 0.6 6.0 Thyroid 0.3 2.7 0.2 2.4 Ovaries 1.2 12.2 1.3 13.3 Testes 0.3 3.1 0.3 3.4 Red Marrow 0.5 4.6 0.5 4.4 Urinary Bladder Wall 1.5 15.5 3.0 30.0 Total Body 0.4 4.2 0.4 4.2 2.3 Instructions for Preparation
Preparation of the Technetium Tc 99m Sestamibi from the Kit for the Preparation of Technetium Tc 99m Sestamibi is done by the following aseptic procedure:
Prior to adding the Sodium Pertechnetate Tc 99m Injection to the vial, inspect the vial carefully for the presence of damage, particularly cracks, and do not use the vial if found. Waterproof gloves should be worn during the preparation procedure. Remove the plastic disc from the vial and swab the top of the vial closure with alcohol to sanitize the surface. Place the vial in a suitable radiation shield with a fitted radiation cap. With a sterile shielded syringe, aseptically obtain additive-free, sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection [925–5550 MBq, (25–150 mCi)] in approximately 1 to 3 mL. Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial in the lead shield. Without withdrawing the needle, remove an equal volume of headspace to maintain atmospheric pressure within the vial. Shake vigorously, about 5 to 10 quick upward-downward motions. Remove the vial from the lead shield and place upright in an appropriately shielded and contained boiling water bath, such that the vial is suspended above the bottom of the bath, and boil for 10 minutes. Timing for 10 minutes is begun as soon as the water begins to boil again. Do not allow the boiling water to come in contact with the aluminum crimp. Remove the vial from the water bath, place in the lead shield and allow to cool for fifteen minutes. Using proper shielding, the vial contents should be visually inspected. Use only if the solution is clear and free of particulate matter and discoloration. Assay the reaction vial using a suitable radioactivity calibration system. Record the Technetium Tc 99m concentration, total volume, assay time and date, expiration time and lot number on the radioassay information label and affix the label to the shield. Store the reaction vial containing the Technetium Tc 99m Sestamibi at 15° to 25°C (59° to 77°F) until use; at such time the product should be aseptically withdrawn. Technetium Tc 99m Sestamibi should be used within six hours of preparation. The vial contains no preservative.
Note: Adherence to the above product reconstitution instructions is recommended.

Mallinckrodt Nuclear Medicine LLC’s Kit for the Preparation of Technetium Tc 99m Sestamibi Injection is not to be used with the Recon-o-Stat™ thermal cycler due to the smaller vial size requirements of this heating device.

The potential for cracking and significant contamination exists whenever vials containing radioactive material are heated.

Product should be used within 6 hours after preparation.

Final product with radiochemical purity of at least 90% was used in the clinical trials that established safety and effectiveness. The radiochemical purity was determined by the following method.
2.4 Determination of Radiochemical Purity in Technetium Tc 99m Sestamibi Obtain a Baker-Flex Aluminum Oxide coated, plastic TLC plate, #1 B-F, pre-cut to 2.5 cm x 7.5 cm. Dry the plate or plates at 100°C for 1 hour and store in a desiccator. Remove pre-dried plate from the desiccator just prior to use. Apply 1 drop of ethanol* using a 1 mL syringe with a 22–26 gauge needle, 1.5 cm from the bottom of the plate. THE SPOT SHOULD NOT BE ALLOWED TO DRY. Add 2 drops of Technetium Tc 99m Sestamibi solution, side by side on top of the ethanol* spot. Return the plate to a desiccator and allow the sample spot to dry (typically 15 minutes). The TLC tank is prepared by pouring ethanol* to a depth of 3–4 mm. Cover the tank and let it equilibrate for ~10 minutes. Develop the plate in the covered TLC tank in ethanol* for a distance of 5 cm from the point of application. Cut the TLC plate 4 cm from the bottom and measure the Tc 99m activity in each piece by appropriate radiation detector. Calculate the % Tc 99m Sestamibi as:

*The ethanol used in this procedure should be 95% or greater. Absolute ethanol (99%) should remain at ≥95% ethanol content for one week after opening if stored tightly capped, in a cool dry place.

No Recall
Walgreens Company

Tolnaftate | Walgreens Company

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks: if conditions persist, consult a doctorto prevent athlete's foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails

No Recall
Taro Pharmaceuticals, Inc.

Tolnaftate | Taro Pharmaceuticals, Inc.

This product is not effective on the scalp or nails.
For athlete's foot and ringworm
use daily for 4 weeks.
For jock itch
use daily for 2 weeks
clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product For athlete's foot
pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, change shoes and socks at least once daily.

No Recall
Neopharm Co., Ltd.

Tolnaftate | Neopharm Co., Ltd.

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once of twice daily (morning and/or night) this product is not effective on the scalp or nails

No Recall
Lifelabs, A Division Of Atico International, Usa, Inc.

Tolnaftate | Lifelabs, A Division Of Atico International, Usa, Inc.

Directions
wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks if condition persists longer consult a doctor this product is not effective on the scalp or nails

No Recall
Kareway Product, Inc.

Tolnaftate | Kareway Product, Inc.

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once of twice daily (morning and/or night) this product is not effective on the scalp or nails

No Recall
Perrigo New York Inc

Tolnaftate | Perrigo New York Inc

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete’s foot: pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. use daily for 4 weeks. If condition lasts longer, ask a doctor. to prevent athlete’s foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails

No Recall
Valu Merchandisers, Co.

Tolnaftate | Valu Merchandisers, Co.

for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails

No Recall
Navarro Discount Pharmacies,llc

Tolnaftate | Navarro Discount Pharmacies,llc

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails

No Recall
Morales Distributors, Inc.

Tolnaftate | Morales Distributors, Inc.

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attentional to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if condition persists longer ask a doctor to prevent athlete's foot, apply once or twice daily (morning and night) this product is not effective on the scalp or nails

No Recall
Major Pharmaceuticals

Tolnaftate | Major Pharmaceuticals

clean the affected area and dry thoroughly apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product
For athlete's foot
use daily for 4 weeks. If condition persists longer, consult a doctor pay special attention to the spaces between the toes wear well fitting ventilated shoes change shoes and socks at least once daily
For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

No Recall
Target Corporation

Tolnaftate | Target Corporation

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if conditions persist, consult a doctor to prevent athlete's foot, appl morning and/or night this product is not effective on the scalp or nails

No Recall
Target Corporation

Tolnaftate | Target Corporation

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if conditions persist, consult a doctor to prevent athlete's foot, apply daily once or twice daily (morning and/or night) in case of clogging, clear nozzle under running water

No Recall
Premier Brands Of America Inc.

Tolnaftate | Premier Brands Of America Inc.

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks for athletes foot, ringworm and for jock itch use daily for 2 weeks if conditions persist, consult a doctor to prevent athlete's foot, apply daily once or twice daily (morning and/or night) this product is not effective on the scalps or nails in case of clogging, clear nozzle under running water

No Recall
Premier Brands Of America Inc.

Tolnaftate | Premier Brands Of America Inc.

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks if conditions persist, consult a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails

No Recall
Premier Brands Of America Inc.

Tolnaftate | Premier Brands Of America Inc.

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product use daily for 2 weeks; if conditions persist, consult a doctor in case of clogging, clear nozzle under running water

No Recall
Premier Brands Of America Inc.

Tolnaftate | Premier Brands Of America Inc.

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if conditions persist, consult a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) in case of clogging, clear nozzle under running water

No Recall
Cvs Pharmacy

Tolnaftate | Cvs Pharmacy

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks for athletes foot, ringworm and for jock itch use daily for 2 weeks if conditions persist, consult a doctor to prevent athlete's foot, apply daily once or twice daily (morning and/or night) this product is not effective on the scalps or nails in case of clogging, clear nozzle under running water

No Recall
Cvs Pharmacy

Tolnaftate | Cvs Pharmacy

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks: if conditions persist, consult a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails

No Recall
Faria Limited Dba Sheffield Pharmaceuticals

Tolnaftate | Faria Limited Dba Sheffield Pharmaceuticals

Clean the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product.
For athlete's foot
Pay special attention to the spaces between the toes. Wear well fitting ventilated shoes. Change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

No Recall