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NDC 54633-0913-04 Tolnaftate 1 g/100g Details
Tolnaftate 1 g/100g
Tolnaftate is a TOPICAL AEROSOL, POWDER in the HUMAN OTC DRUG category. It is labeled and distributed by The Podiatree Company. The primary component is TOLNAFTATE.
MedlinePlus Drug Summary
Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 54633-0913-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tolnaftate
Product Information
| NDC | 54633-0913 |
|---|---|
| Product ID | 54633-913_60b9aa2d-ae5b-567b-e053-2a91aa0a1e29 |
| 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 | Tolnaftate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Antifungal Powder Spray |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | AEROSOL, POWDER |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | TOLNAFTATE |
| Labeler Name | The Podiatree Company |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333C |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 54633-0913-04 (54633091304)
| NDC Package Code | 54633-913-04 |
|---|---|
| Billing NDC | 54633091304 |
| Package | 130 g in 1 CANISTER (54633-913-04) |
| Marketing Start Date | 2013-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 60b9aa2d-ae5c-567b-e053-2a91aa0a1e29 Details
Uses
Warnings
For external use only.
Flammable:
Do not use near heat or flame, or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
When using this product
- Do not get into eyes or mouth
- Use only as directed
- Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
Directions
- Wash affected area and dry thoroughly
- Shake can well and spray a thin layer over the 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- Use daily for 4 weeks for athletes foot, ringworm; use daily for 2 weeks for jock itch
- If conditions persist, consult a doctor
- To prevent athlete's foot, apply daily (morning and night)
- This product is not effective on the scalps or nails
- In case of clogging, clear nozzle under running water
Questions or Suggestions?
INGREDIENTS AND APPEARANCE
| TOLNAFTATE
antifungal powder spray aerosol, powder |
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| Labeler - The Podiatree Company (078656000) |
Revised: 12/2017
Document Id: 60b9aa2d-ae5b-567b-e053-2a91aa0a1e29
Set id: 60b9aa2d-ae5c-567b-e053-2a91aa0a1e29
Version: 3
Effective Time: 20171219