Label: TOLNAFTATE CREAM 1% ANTIFUNGAL- tolnaftate cream
- NDC Code(s): 69396-016-05, 69396-016-20
- Packager: Trifecta Pharmaceuticals Usa Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 January 17, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
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Warnings
For external use only.
When using this product avoid contact with the eyes.
Stop use and ask a healthcare professional if ● irritation occurs ● there is no improvement within 4 weeks improvement
Do not use on children under 2 years of age except under the advice and supervision of a healthcare professional.
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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 shoes and socks at least once daily.
● use daily for 4 weeks; if conditions persists longer, ask a healthcare professional.
● to prevent athlete's foot, apply once or twice daily (morning and/or night)
● this product is not effective on the scalp or nails.
- Inactive ingredients
- Other information
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
TOLNAFTATE CREAM 1% ANTIFUNGAL
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) LIGHT MINERAL OIL (UNII: N6K5787QVP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-016-20 1 in 1 BOX 04/09/2016 1 30 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69396-016-05 1 in 1 BOX 04/09/2016 2 15 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/09/2016 Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)
