Label: ANTI-FUNGAL- tolnaftate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 53807-123-45 - Packager: Rij Pharmaceutical Corporation
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 30, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- INDICATIONS & USAGE
- Warnings
- Keep out of reach of children.
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Directions
- shake well before use
- clean the 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
- this product is not effective on the scalp or nails
For athletes foot
- use daily for 4 weeks
- pay special attention to the spaces between the toes
- wear well-fitting, ventilated shoes
- change shoes and socks at least once a daily
- to prevent athlete's foot: clean and dry feet thoroughly, apply once or twice daily
For jock itch
- use daily for 2 weeks
- Other information
- Inactive ingredients
- Package Label Display
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INGREDIENTS AND APPEARANCE
ANTI-FUNGAL
tolnaftate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE .45 g in 45 g Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-123-45 45 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 03/16/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/16/1999 Labeler - Rij Pharmaceutical Corporation (144679156) Establishment Name Address ID/FEI Business Operations Rij Pharmaceutical Corporation 144679156 manufacture(53807-123)