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NDC 00363-2101-08 Jock Itch 10 mg/g Details
Jock Itch 10 mg/g
Jock Itch is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is BUTENAFINE HYDROCHLORIDE.
Product Information
NDC | 00363-2101 |
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Product ID | 0363-2101_4c018fd2-bfdc-4f58-b62a-d4c39ce5d6fa |
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 | Jock Itch |
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 | Walgreen Company |
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 00363-2101-08 (00363210108)
NDC Package Code | 0363-2101-08 |
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Billing NDC | 00363210108 |
Package | 1 TUBE in 1 CARTON (0363-2101-08) / 12 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 6b13e8ad-b7dd-49e7-9469-3cac077c763e 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
- 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
JOCK ITCH
butenafine hydrochloride cream |
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Labeler - Walgreen Company (008965063) |
Revised: 11/2017
Document Id: 4c018fd2-bfdc-4f58-b62a-d4c39ce5d6fa
Set id: 6b13e8ad-b7dd-49e7-9469-3cac077c763e
Version: 2
Effective Time: 20171121