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NDC 45802-0434-01 clotrimazole 1 g/100g Details
clotrimazole 1 g/100g
clotrimazole is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. 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: 45802-0434-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clotrimazole Topical
Product Information
| NDC | 45802-0434 |
|---|---|
| Product ID | 45802-434_3c4930b8-dc88-4075-9232-8dd99ab097da |
| Associated GPIs | 90154020003705 |
| GCN Sequence Number | 007361 |
| GCN Sequence Number Description | clotrimazole CREAM (G) 1 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 30370 |
| HICL Sequence Number | 004137 |
| HICL Sequence Number Description | CLOTRIMAZOLE |
| Brand/Generic | Generic |
| 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 | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | CLOTRIMAZOLE |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| 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 45802-0434-01 (45802043401)
| NDC Package Code | 45802-434-01 |
|---|---|
| Billing NDC | 45802043401 |
| Package | 1 TUBE in 1 CARTON (45802-434-01) / 15 g in 1 TUBE |
| Marketing Start Date | 2011-06-03 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.14557 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | CLOTRIMAZOLE 1% TOPICAL CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 3dcd0158-ec51-4fa7-a26a-02c2926156c0 Details
Uses
Warnings
Directions
- •
- wash the 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 the 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, consult a doctor
- •
- this product is not effective on the scalp or nails
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| CLOTRIMAZOLE
clotrimazole cream |
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| Labeler - Padagis Israel Pharmaceuticals Ltd (600093611) |
Revised: 11/2021
Document Id: 3c4930b8-dc88-4075-9232-8dd99ab097da
Set id: 3dcd0158-ec51-4fa7-a26a-02c2926156c0
Version: 6
Effective Time: 20211111