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NDC 36800-0049-01 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 TOPCO ASSOCIATES LLC. The primary component is BUTENAFINE HYDROCHLORIDE.
Product Information
| NDC | 36800-0049 |
|---|---|
| Product ID | 36800-049_a0c731ca-4dec-4150-9732-a3320468ac12 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| 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 | TOPCO ASSOCIATES LLC |
| 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 36800-0049-01 (36800004901)
| NDC Package Code | 36800-049-01 |
|---|---|
| Billing NDC | 36800004901 |
| Package | 1 TUBE in 1 CARTON (36800-049-01) / 12 g in 1 TUBE |
| Marketing Start Date | 2017-12-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3e976ed8-2af8-4d1e-bda6-e2f672c7ec03 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 - 12 g Tube Carton
INGREDIENTS AND APPEARANCE
| ATHLETES FOOT
butenafine hydrochloride cream |
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| Labeler - TOPCO ASSOCIATES LLC (006935977) |
Revised: 8/2018
Document Id: a0c731ca-4dec-4150-9732-a3320468ac12
Set id: 3e976ed8-2af8-4d1e-bda6-e2f672c7ec03
Version: 2
Effective Time: 20180815