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NDC 71399-0501-02 Clotrimazole 10 mg/g Details
Clotrimazole 10 mg/g
Clotrimazole is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Akron Pharma Inc. The primary component is CLOTRIMAZOLE.
MedlinePlus Drug Summary
Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Related Packages: 71399-0501-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Clotrimazole Topical
Product Information
| NDC | 71399-0501 |
|---|---|
| Product ID | 71399-0501_d4b5116d-3a42-32df-e053-2995a90a55e6 |
| 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 | Clotrimazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Clotrimazole |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/g |
| Substance Name | CLOTRIMAZOLE |
| Labeler Name | Akron Pharma Inc |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333C |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 71399-0501-02 (71399050102)
| NDC Package Code | 71399-0501-2 |
|---|---|
| Billing NDC | 71399050102 |
| Package | 1 TUBE in 1 CARTON (71399-0501-2) / 15 g in 1 TUBE |
| Marketing Start Date | 2022-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d4b5116d-3a41-32df-e053-2995a90a55e6 Details
Uses
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- wash affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- for athlete's foot, pay special sttention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch , use daily for 2 weeks
- if condition persists longer, ask a doctor
- this prodcut is not effective on the scalp or nails
Inactive Ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| CLOTRIMAZOLE
clotrimazole cream |
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| Labeler - Akron Pharma Inc (067878881) |
Revised: 1/2022
Document Id: d4b5116d-3a42-32df-e053-2995a90a55e6
Set id: d4b5116d-3a41-32df-e053-2995a90a55e6
Version: 1
Effective Time: 20220103