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NDC 00363-2083-01 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 Walgreen Company. The primary component is TERBINAFINE HYDROCHLORIDE.
Product Information
NDC | 00363-2083 |
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Product ID | 0363-2083_aab4fe7d-4fa1-4751-b681-3d041dc116ce |
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 | Walgreen Company |
Pharmaceutical Class | Allylamine Antifungal [EPC], Allylamine [CS] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA077511 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 00363-2083-01 (00363208301)
NDC Package Code | 0363-2083-01 |
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Billing NDC | 00363208301 |
Package | 1 TUBE in 1 CARTON (0363-2083-01) / 15 g in 1 TUBE |
Marketing Start Date | 2012-12-12 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d985c2a4-c0e8-4d87-9fcd-2b1aeda0198e 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 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
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
INGREDIENTS AND APPEARANCE
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride cream |
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Labeler - Walgreen Company (008965063) |
Revised: 7/2017
Document Id: aab4fe7d-4fa1-4751-b681-3d041dc116ce
Set id: d985c2a4-c0e8-4d87-9fcd-2b1aeda0198e
Version: 2
Effective Time: 20170717