Family Wellness Antifungal
FDA Label NDC 55319-334

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar for the product Family Wellness Antifungal (NDC 55319-334). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                              Purpose

Clotrimazole 1%............................................... Antifungal

Otc - Purpose

Uses

  • Cures most athlete's foot, jock itch, and ringworm
  • Relieves itching, burning, cracking, scaling, and discomfort

Warnings

Warnings

For external use only.

Otc - Do Not Use

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

Otc - When Using

When using this product avoid contact with eyes.

Otc - Stop Use

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)
  • do not use for diaper rash

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 thick 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 a day
  • For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
  • In condition persists longer, ask a doctor
  • This product is no 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

2-octyldodecanol, benzyl alcohol, cetearyl alcohol, cetyl esters, monobasic sodium phosphate dihydrate, polysorbate 60, proylene glycol, purified water, sorbitan stearate

Dosage & Administration

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES INC.

10401 MONROE RD.

MATTHEWS, NC 28105 USA

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