Label: TOLNAFTATE ANTIFUNGAL- tolnaftate cream
- NDC Code(s): 24385-032-03
- Packager: Amerisource Bergen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- helps prevent most athlete's foot with daily use
- for effective relief of
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
This product is not effective on the scalp or nails.
For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
- clean the 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 athlete's foot
pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily
- Other information
- store at room temperature
- see carton or tube crimp for lot number and expiration date
- Inactive ingredients
BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatumClose
- SPL UNCLASSIFIED SECTION
1300 Morris Drive
Chesterbrook, PA 19087
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
Compare to the Tinactin® active ingredient*
Tolnaftate 1% Cream
Cures & Prevents Most Athlete's Foot
NET WT 1 oz (30 g)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-032 Route of Administration TOPICAL DEA Schedule 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) titanium dioxide (UNII: 15FIX9V2JP) petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24385-032-03 1 in 1 CARTON 1 30 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 02/17/2006 Labeler - Amerisource Bergen (007914906) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(24385-032)