Label: ANTIFUNGAL- tolnaftate cream
- NDC Code(s): 11822-0701-1, 11822-0701-2
- Packager: Rite Aid Corporation
- 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.
Updated January 21, 2013
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- Active ingredient
- proven clinically effective in the treatment of most
- athlete’s foot (tinea pedis)
- ringworm (tinea corporis)
- helps prevent most athlete’s foot with daily use
- for effective relief of
For external use only
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- 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.
- use daily for 4 weeks. If condition lasts longer, ask 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
- Other information
store at 68°-77°F (20°-25°C)Close
- Inactive ingredients
butylated hydroxytoluene, carbomer homopolymer, monoamylamine, PEG-400, propylene glycol, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredient of Tinactin® Antifungal Cream
relieves itching & burning
cures and prevents most athlete’s footClose
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0701 Route of Administration TOPICAL DEA Schedule 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PENTYLAMINE (UNII: E05QM3V8EF) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0701-1 1 in 1 CARTON 1 14 g in 1 TUBE 2 NDC:11822-0701-2 1 in 1 CARTON 2 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/23/2005 Labeler - Rite Aid Corporation (014578892)