Label: TOPCARE TOLNAFTATE ANTIFUNGAL- tolnaftate cream
- NDC Code(s): 36800-052-60
- Packager: Topco Associates LLC
- 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
For external use only
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 dailyClose
- Other information
- store at controlled 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
TOPCO ASSOCIATES LLC
7711 GROSS POINT RD
SKOKIE, IL 60077
- PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
CURES AND PREVENTS MOST ATHLETE'S FOOT
TOLNAFTATE 1% CREAM
NET WT 0.5 OZ (14.2 g)
- INGREDIENTS AND APPEARANCE
TOPCARE TOLNAFTATE ANTIFUNGAL
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-052 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tolnaftate (Tolnaftate) Tolnaftate 10 mg in 1 g Inactive Ingredients Ingredient Name Strength Butylated Hydroxytoluene Polyethylene glycol 400 Polyethylene glycol 3350 titanium dioxide petrolatum Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-052-60 1 in 1 CARTON 1 14.2 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 - Topco Associates LLC (006935977) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(36800-052)