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NDC 51672-2100-01 Athletes Foot 10 mg/g Details
Athletes Foot 10 mg/g
Athletes Foot is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., inc.. The primary component is BUTENAFINE HYDROCHLORIDE.
Product Information
| NDC | 51672-2100 |
|---|---|
| Product ID | 51672-2100_2c67420b-73a6-4382-bc58-fc031ac3e6af |
| Associated GPIs | 90150026103720 |
| GCN Sequence Number | 029333 |
| GCN Sequence Number Description | butenafine HCl CREAM (G) 1 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 37521 |
| HICL Sequence Number | 012258 |
| HICL Sequence Number Description | BUTENAFINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Athletes Foot |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Butenafine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/g |
| Substance Name | BUTENAFINE HYDROCHLORIDE |
| Labeler Name | Taro Pharmaceuticals U.S.A., inc. |
| Pharmaceutical Class | Benzylamine Antifungal [EPC], Benzylamines [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205181 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51672-2100-01 (51672210001)
| NDC Package Code | 51672-2100-1 |
|---|---|
| Billing NDC | 51672210001 |
| Package | 1 TUBE in 1 CARTON (51672-2100-1) / 15 g in 1 TUBE |
| Marketing Start Date | 2017-11-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4b400be5-acaa-4a5f-b8ef-c0df8ad6175f Details
Uses
Warnings
Directions
- 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 between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
Apply between and around the toes
1 week twice a day or 4 weeks once a day
- for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor.
- wash hands after each use
- children under 12 years: ask a doctor
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
INGREDIENTS AND APPEARANCE
| ATHLETES FOOT
butenafine hydrochloride cream |
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| Labeler - Taro Pharmaceuticals U.S.A., inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(51672-2100) | |
Revised: 11/2017
Document Id: 2c67420b-73a6-4382-bc58-fc031ac3e6af
Set id: 4b400be5-acaa-4a5f-b8ef-c0df8ad6175f
Version: 4
Effective Time: 20171120