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NDC 36800-0495-69 TopCare 10 mg/g Details
TopCare 10 mg/g
TopCare is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. 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: 36800-0495-69Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clotrimazole Topical
Product Information
| NDC | 36800-0495 |
|---|---|
| Product ID | 36800-495_2feb1ba9-9227-4aad-a2e2-2d4243d0ac0f |
| 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 | TopCare |
| Proprietary Name Suffix | Antifungal |
| 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 | Topco Associates LLC |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333C |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0495-69 (36800049569)
| NDC Package Code | 36800-495-69 |
|---|---|
| Billing NDC | 36800049569 |
| Package | 1 TUBE in 1 CARTON (36800-495-69) / 14.2 g in 1 TUBE |
| Marketing Start Date | 1993-08-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6757eb2a-73e0-4bd0-a332-5713fdf3445d Details
Uses
Warnings
Directions
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change 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 product is not effective on the scalp or nails
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
INGREDIENTS AND APPEARANCE
| TOPCARE
ANTIFUNGAL
clotrimazole cream |
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| Labeler - Topco Associates LLC (006935977) |
| Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(36800-495) | |
Revised: 3/2019
Document Id: 2feb1ba9-9227-4aad-a2e2-2d4243d0ac0f
Set id: 6757eb2a-73e0-4bd0-a332-5713fdf3445d
Version: 2
Effective Time: 20190307