Label: ANTIFUNGAL MEDICATED BODY WASH- tolnaftate gel
- NDC Code(s): 83004-012-01, 83004-012-02, 83004-012-03, 83004-012-04
- Packager: Rida LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 5, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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WARNINGS
Warning
For external use only.
When using this product
When using this product avoid contact with the eyeStop use and ask a doctor ifirritation occurs or if there is no
improvement within 2 weeks for jock itch or within 4 weeks for athlete's
foot and ringworm.Do not use
Do Not use on children under 2 under of age except under the advice
and supervision of a doctor.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Make sure to dry affected area thoroughly.
- Supervise children in the use of this product.
- For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
- Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
- This product is not effective on the scalp or nails.
- Inactive ingredients
- Product label
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL MEDICATED BODY WASH
tolnaftate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83004-012 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 TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) SODIUM GLUCONATE (UNII: R6Q3791S76) SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) GLYCERIN (UNII: PDC6A3C0OX) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) SODIUM CHLORIDE (UNII: 451W47IQ8X) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) SODIUM COCOATE (UNII: R1TQH25F4I) SODIUM PALMATE (UNII: S0A6004K3Z) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83004-012-01 56 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/06/2024 2 NDC:83004-012-02 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/06/2024 3 NDC:83004-012-03 226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/06/2024 4 NDC:83004-012-04 453 g in 1 PACKAGE; Type 0: Not a Combination Product 06/06/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 06/06/2024 Labeler - Rida LLC (004425803)
