Label: NATUREPLEX TOLNAFTATE ANTIFUNGAL- tolnaftate cream
- NDC Code(s): 67234-032-01
- Packager: Natureplex, LLC
- 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 December 5, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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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 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
- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
- if condition persists longer, ask a doctor
- this product is not effective on scalp or nails
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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INGREDIENTS AND APPEARANCE
NATUREPLEX TOLNAFTATE ANTIFUNGAL
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-032 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) CETYL ALCOHOL (UNII: 936JST6JCN) CHLOROCRESOL (UNII: 36W53O7109) MINERAL OIL (UNII: T5L8T28FGP) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-032-01 1 in 1 CARTON 09/23/1993 1 28 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 09/23/1993 Labeler - Natureplex, LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-032)