FDA Label for Topcare Tolnaftate Antifungal

View Indications, Usage & Precautions

Topcare Tolnaftate Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

For external use only.

Avoid contact with eyes.

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007


Active Ingredient



Tolnaftate 1%


Purpose



Antifungal


Uses



  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort

Otc - Do Not Use



Do not use on children under 2 years of age unless directed by a doctor.


Stop Use And Ask A Doctor If



  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch

Otc - Pregnancy Or Breast Feeding



If pregnant of breastfeeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.


Directions



  • wash affected area and dry thoroughly
  • apply a thin layer 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 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, consult a doctor
  • this product is not effective on the scalp or nails

Other Information



  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients



ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol


Questions Or Comments?



866-323-0107 or www.natureplex.com


Principal Display Panel - 14 G Tube Carton



NDC 36800-052-60

TopCare
health

PRESCRIPTION STRENGTH

Athlete's Foot Cream

TOLNAFTATE CREAM 1% • ANTIFUNGAL

• OUR PHARMACISTS •
RECOMMEND

NET WT 0.5 OZ (14 g)


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