Gelato Topical Anesthetic

Gelato Topical Anesthetic

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Side Effects & Adverse Reactions

Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
When using this product: avoid contact with eyes. If contact occurs, flush with water.
Stop use and consult a healthcare practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
If pregnant or breast feeding, ask a health professional before use.

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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 oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

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History

There is currently no drug history available for this drug.

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Other Information

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Sources

Gelato Topical Anesthetic Manufacturers

Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert tray into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectivenesss).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

A single metered spray dispenses 50mg of Gelato Topical Anesthetic. Use only as directed by a dentist.

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Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Drunk Elephant Distributors, Llc

APPLY LIBERALLY 20 MINUTES PRIOR TO SUN EXPOSURE AS NEEDED. REAPPLY: AFTER SWIMMING OR SWEATING, IMMEDIATELY AFTER TOWEL DRYING, AT LEAST EVERY TWO HOURS. DO NOT USE ON INFANTS UNDER 6 MONTHS OF AGE. SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREEASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

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Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Salado Sales, Inc.

adults and children 12 years and older: take 2 tablets at bedtime if needed or as directed by a doctor children under 12 years: do not use

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Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Teva Pharmaceuticals Usa Inc

Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Do not crush or cut capecitabine tablets. Capecitabine tablets dose is calculated according to body surface area.
2.1 Standard Starting Dose
Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)

The recommended dose of capecitabine tablets is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles (see Table 1).

Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months [i.e., capecitabine tablets 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks)].
Table 1: Capecitabine Tablets Dose Calculation According to Body Surface Area * Total Daily Dose divided by 2 to allow equal morning and evening doses
Dose Level 1250 mg/m2
Twice a Day

Number of Tablets to be Taken at Each Dose (Morning and Evening)

Surface Area (m2)

Total Daily Dose* (mg)

150 mg

500 mg

≤ 1.25

3000

0

3

1.26 to 1.37

3300

1

3

1.38 to 1.51

3600

2

3

1.52 to 1.65

4000

0

4

1.66 to 1.77

4300

1

4

1.78 to 1.91

4600

2

4

1.92 to 2.05

5000

0

5

2.06 to 2.17

5300

1

5

≥ 2.18

5600

2

5

In Combination With Docetaxel (Metastatic Breast Cancer)

In combination with docetaxel, the recommended dose of capecitabine tablets is 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m2 as a 1-hour intravenous infusion every 3 weeks. Pre-medication, according to the docetaxel labeling, should be started prior to docetaxel administration for patients receiving the capecitabine tablets plus docetaxel combination. Table 1 displays the total daily dose of capecitabine tablets by body surface area and the number of tablets to be taken at each dose.
2.2 Dose Management Guidelines
General

Capecitabine tablets dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of capecitabine tablets should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies (14)]. Toxicity due to capecitabine tablet administration may be managed by symptomatic treatment, dose interruptions and adjustment of capecitabine tablets dose. Once the dose has been reduced, it should not be increased at a later time. Doses of capecitabine tablets omitted for toxicity are not replaced or restored; instead the patient should resume the planned treatment cycles.

The dose of phenytoin and the dose of coumarin-derivative anticoagulants may need to be reduced when either drug is administered concomitantly with capecitabine tablets [see Drug Interactions (7.1)].

Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)

Capecitabine tablets dose modification scheme as described below (see Table 2) is recommended for the management of adverse reactions.
Table 2: Recommended Dose Modifications of Capecitabine Tablets * National Cancer Institute of Canada Common Toxicity Criteria were used except for the hand-and-foot syndrome [see Warnings and Precautions (5)].
Toxicity NCIC Grades*

During a Course of Therapy

Dose Adjustment for Next Treatment (% of starting dose)

Grade 1

Maintain dose level

Maintain dose level

Grade 2

-1st appearance

Interrupt until resolved to grade 0 to 1

100%

-2nd appearance

75%

-3rd appearance

50%

-4th appearance

Discontinue treatment permanently

-

Grade 3

-1st appearance

Interrupt until resolved to grade 0 to 1

75%

-2nd appearance

50%

-3rd appearance

Discontinue treatment permanently

-

Grade 4

-1st appearance

Discontinue permanently
OR
If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0 to 1

50%

In Combination With Docetaxel (Metastatic Breast Cancer)

Dose modifications of capecitabine tablets for toxicity should be made according to Table 2 above for capecitabine tablets. At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine tablets or docetaxel, then administration of both agents should be delayed until the requirements for restarting both drugs are met.

The dose reduction schedule for docetaxel when used in combination with capecitabine tablets for the treatment of metastatic breast cancer is shown in Table 3.
Table 3: Docetaxel Dose Reduction Schedule in Combination with Capecitabine Tablets * National Cancer Institute of Canada Common Toxicity Criteria were used except for hand-and-foot syndrome [see Warnings and Precautions (5)].
Toxicity NCIC Grades*

Grade 2

Grade 3

Grade 4

1st appearance

Delay treatment until resolved to grade 0 to 1; Resume treatment with original dose of 75 mg/m2 docetaxel

Delay treatment until resolved to grade 0 to 1; Resume treatment at 55 mg/m2 of docetaxel.

Discontinue treatment with docetaxel

2nd appearance

Delay treatment until resolved to grade 0 to 1; Resume treatment at 55 mg/m2 of docetaxel.

Discontinue treatment with docetaxel

-

3rd appearance

Discontinue treatment with docetaxel

-

-
2.3 Adjustment of Starting Dose in Special Populations
Renal Impairment

No adjustment to the starting dose of capecitabine tablets is recommended in patients with mild renal impairment (creatinine clearance = 51 to 80 mL/min [Cockroft and Gault, as shown below]). In patients with moderate renal impairment (baseline creatinine clearance = 30 to 50 mL/min), a dose reduction to 75% of the capecitabine tablets starting dose when used as monotherapy or in combination with docetaxel (from 1250 mg/m2 to 950 mg/m2 twice daily) is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Subsequent dose adjustment is recommended as outlined in Table 2 and Table 3 (depending on the regimen) if a patient develops a grade 2 to 4 adverse event [see Warnings and Precautions (5.5)]. The starting dose adjustment recommendations for patients with moderate renal impairment apply to both capecitabine tablets monotherapy and capecitabine tablets in combination use with docetaxel.

Cockroft and Gault Equation:

(140 - age [yrs]) (body wt [kg])

Creatinine clearance for males =

—————————————

(72) (serum creatinine [mg/dL])

Creatinine clearance for females = 0.85 × male value

Geriatrics

Physicians should exercise caution in monitoring the effects of capecitabine tablets in the elderly. Insufficient data are available to provide a dosage recommendation.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Medicine Shoppe International Inc

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years
of age and over 1 to 2 capsules
children 6 to under 12 years
of age
1 capsule children under 6 years of age do not use this product in
children under 6 years of age

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall

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