Terbinafine Hydrochloride

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Terbinafine Hydrochloride Recall

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Side Effects & Adverse Reactions

For external use only

on nails or scalp
in or near the mouth or the eyes
for vaginal yeast infections

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

too much irritation occurs or gets worse.
side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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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

cures most athlete's foot (tinea pedis)
cures most jock itch (tinea cruris) and ringworm (tinea corporis)
relieves itching, burning, cracking and scaling which accompany these conditions

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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.

Sources

Terbinafine Hydrochloride Manufacturers

Remedyrepack Inc.

Terbinafine Hydrochloride | Remedyrepack Inc.

adults and children 12 years and older use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor 1 week between the toes

2 weeks on the bottom or sides of the foot

No Recall
Wockhardt Usa, Llc

Terbinafine Hydrochloride | Wockhardt Usa, Llc

Terbinafine Hydrochloride Tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients with fingernail onychomycosis. Terbinafine hydrochloride, one 250 mg tablet, should be taken once daily for 12 weeks by patients with toenail onychomycosis. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Rebel Distributors Corp

Terbinafine Hydrochloride | Rebel Distributors Corp

Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients with fingernail onychomycosis. Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 12 weeks by patients with toenail onychomycosis. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Preferred Pharmaceuticals, Inc

Terbinafine Hydrochloride | Preferred Pharmaceuticals, Inc

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Terbinafine Hydrochloride | Taro Pharmaceuticals U.s.a., Inc.

adults and children 12 years and older use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor 1 week between the toes

2 weeks on the bottom or sides of the foot

No Recall
Cardinal Health

Terbinafine Hydrochloride | Cardinal Health

adults and children 12 years and older use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor 1 week
between the toes 2 weeks on the bottom
or sides of the foot

No Recall
Pd-rx Pharmaceuticals, Inc.

Terbinafine Hydrochloride | Pd-rx Pharmaceuticals, Inc.

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Preferred Pharmaceuticals, Inc

Terbinafine Hydrochloride | Preferred Pharmaceuticals, Inc

• adults and children 12 years and older ∘ use the tip of the cap to break the seal and open the tube ∘ wash the affected skin with soap and water and dry completely before applying ∘ for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. ▪ between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. ▪ on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. ∘ for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. ∘ wash hands after each use • children under 12 years: ask a doctor
1 week between the toes

2 weeks on the bottom or sides of the foot

No Recall
Avkare, Inc.

Terbinafine Hydrochloride | Avkare, Inc.

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Golden State Medical Supply, Inc.

Terbinafine Hydrochloride | Golden State Medical Supply, Inc.

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Dr.reddys Laboratories Limited

Terbinafine Hydrochloride | Dr.reddys Laboratories Limited

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Wockhardt Limited

Terbinafine Hydrochloride | Wockhardt Limited

Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients with fingernail onychomycosis. Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 12 weeks by patients with toenail onychomycosis. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Wockhardt Usa Llc.

Terbinafine Hydrochloride | Wockhardt Usa Llc.

Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients with fingernail onychomycosis. Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 12 weeks by patients with toenail onychomycosis. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Camber Pharmaceuticals

Terbinafine Hydrochloride | Camber Pharmaceuticals, Inc.

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Bryant Ranch Prepack

Terbinafine Hydrochloride | Bryant Ranch Prepack

Terbinafine Hydrochloride Tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients with fingernail onychomycosis. Terbinafine hydrochloride, one 250 mg tablet, should be taken once daily for 12 weeks by patients with toenail onychomycosis. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Walgreen Company

Terbinafine Hydrochloride | Walgreen Company

adults and children 12 years and older use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for jock itch apply once a day (morning or night) for 1 week or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor

No Recall
Remedyrepack Inc.

Terbinafine Hydrochloride | Remedyrepack Inc.

●●
Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Chain Drug Constortium

Terbinafine Hydrochloride | Chain Drug Constortium

adults and children 12 years and older use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor 1 week between the toes

2 weeks on the bottom
or sides of the foot

No Recall
Northstar Rx Llc

Terbinafine Hydrochloride | Northstar Rx Llc

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Physicians Total Care, Inc.

Terbinafine Hydrochloride | Physicians Total Care, Inc.

adults and children 12 years and older use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor 1 week between the toes

2 weeks on the bottom or sides of the foot

No Recall
Proficient Rx Lp

Terbinafine Hydrochloride | Proficient Rx Lp

• adults and children 12 years and older • use the tip of the cap to break the seal and open the tube • wash the affected skin with soap and water and dry completely before applying • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. • wash hands after each use • children under 12 years: ask a doctor
1 week between the toes

2 weeks on the bottom or sides of the foot

No Recall
Breckenridge Pharmaceutical, Inc.

Terbinafine Hydrochloride | Breckenridge Pharmaceutical, Inc.

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Carilion Materials Management

Terbinafine Hydrochloride | Carilion Materials Management

● ●
Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Harris Pharmaceutical, Inc.

Terbinafine Hydrochloride | Harris Pharmaceutical, Inc.

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
American Health Packaging

Terbinafine Hydrochloride | American Health Packaging

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall
Directrx

Terbinafine Hydrochloride | Directrx

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

No Recall