Label: MEIJER ANTIFUNGAL TOLNAFTATE CREAM- tolnaftate cream
- NDC Code(s): 79481-8229-1
- Packager: MEIJER, INC.
- 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 December 15, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Directions
- wash 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
- for athelete's foot: pay special attention to 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. If condition persists longer, consult a doctor.
- to prevent athlete's foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEIJER ANTIFUNGAL TOLNAFTATE CREAM
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-8229 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM SULFITE (UNII: VTK01UQK3G) STEARETH-20 (UNII: L0Q8IK9E08) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARIC ACID (UNII: 4ELV7Z65AP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ETHYLPARABEN (UNII: 14255EXE39) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-8229-1 1 in 1 CARTON 07/16/2020 1 14 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 07/16/2020 Labeler - MEIJER, INC. (006959555)