Label: THERACARE ANTIFUNGAL CREAM- tolnaftate cream
- NDC Code(s): 71101-934-01
- Packager: Veridian Healthcare
- 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 June 30, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
-
Directions
adults and children 2 years of age and over:
- 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
- to prevent athlete's foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
Children under 2 years of age: consult a physician
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton
-
INGREDIENTS AND APPEARANCE
THERACARE ANTIFUNGAL CREAM
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-934 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 CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51) PETROLATUM (UNII: 4T6H12BN9U) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM PHOSPHATE (UNII: SE337SVY37) Product Characteristics Color white (White to Off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71101-934-01 1 in 1 CARTON 06/01/2022 1 35.4 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 06/01/2022 Labeler - Veridian Healthcare (830437997) Registrant - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations ANICARE PHARMACEUTICALS PRIVATE LIMITED 916837425 manufacture(71101-934)