Natureplex Tolnaftate Cream
FDA Label NDC 67234-032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natureplex, Llc for the product Natureplex Tolnaftate (NDC 67234-032). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, and discomfort that accompany these conditions

Warnings

For external use only.

Otc - Do Not Use

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

When Using This Product

  • avoid contact with eyes

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 - 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)
  • supervise children in 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, ask a doctor
  • this product is not effective on 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 BROKEN OR MISSING.

Inactive Ingredients

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

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel - 28 G Tube Carton

Natureplex™

TOLNAFTATE

Antifungal Cream

NET WT. 1 Oz. (28g)

Principal Display Panel (28 g Tube Carton)

Principal Display Panel (28 g Tube Carton)

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