Premier Value Tolnaftate Antifungal
FDA Label NDC 68016-014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Premier Value Tolnaftate Antifungal (NDC 68016-014). 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 - when using, otc - stop use, otc - do not 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

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

Otc - Purpose

Uses

  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot
  • effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

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 Poison 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) 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

Storage And Handling

Other Information

Lot No. and Exp. Date: see box or see crimp of the tube.  Store between 20o to 25oC (68o to 77oF)

Inactive Ingredient

Inactive Ingredients

Propylene glycol, liquid paraffin, stearyl alchol, cetyl alcohol, sorbitan monstearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben.

Dosage & Administration

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

3301 N.W. BOCA RATON BLVD., SUITE 101

BOCA RATON, FL 33431

MADE IN KOREA

Package Label.Principal Display Panel

Image Of Carton Label (Premiervaluetolnaftate)

Image Of Carton Label (Premiervaluetolnaftate)

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