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NDC 51672-2140-01 Terbinafine Hydrochloride 1 g/100g Details
Terbinafine Hydrochloride 1 g/100g
Terbinafine Hydrochloride 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 TERBINAFINE HYDROCHLORIDE.
Product Information
NDC | 51672-2140 |
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Product ID | 51672-2140_1c64a256-9269-4068-9f7a-cb6b62a2af19 |
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 | Terbinafine Hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Terbinafine Hydrochloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 1 |
Active Ingredient Units | g/100g |
Substance Name | TERBINAFINE HYDROCHLORIDE |
Labeler Name | Taro Pharmaceuticals U.S.A., Inc. |
Pharmaceutical Class | Allylamine Antifungal [EPC], Allylamine [CS] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA077511 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 51672-2140-01 (51672214001)
NDC Package Code | 51672-2140-1 |
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Billing NDC | 51672214001 |
Package | 1 TUBE in 1 CARTON (51672-2140-1) / 15 g in 1 TUBE |
Marketing Start Date | 2019-02-28 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ca9cd2bd-4805-4469-b754-01a7487b71a6 Details
Uses
Warnings
Directions
- adults and children 12 years and over
- 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 | |
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Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
INGREDIENTS AND APPEARANCE
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride cream |
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Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(51672-2140) |
Revised: 3/2021
Document Id: 1c64a256-9269-4068-9f7a-cb6b62a2af19
Set id: ca9cd2bd-4805-4469-b754-01a7487b71a6
Version: 2
Effective Time: 20210304