FDA Label for Family Wellness Antifungal

View Indications, Usage & Precautions

Family Wellness Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Family Dollar. 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.

Otc - Active Ingredient



Active Ingredient                                            Purpose

Tolnaftate 1%................................................ Antifungal


Otc - Purpose



Uses

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning, and cracking

Warnings



Warnings

For external use only


Otc - When Using



When using this product avoid contact with the eyes


Otc - Stop Use



Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Otc - Do Not Use



Do not use on children under 2 years of age except under the advice and supervision of a doctor


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poision Control Center right away.


Indications & Usage



Directions

  • 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 conditions persist longer, ask 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

Storage And Handling



Other information

  • lot no. & exp. date: see box or see crimp of the tube
  • store between 20°C to 25°C (68°F to 77°F)

Inactive Ingredient



Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monorask sodium phosphate dilhydrate, propylene glycol, purified water, white petrolatum


Dosage & Administration



DISTRIBUTED BY:

FAMILY DOLLAR SERVICES INC.

10401 MONROE RD.

MATTHEWS, NC 28105 USA


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