Walgreens Clotrimazole Antifungal
FDA Label NDC 0363-7412

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Clotrimazole Antifungal (NDC 0363-7412). 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

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

Otc - Purpose

Uses

  • cures most ringworm
  • relieves itching, redness, irritation and discomfort which accompany this condition

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 unless directed by 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 immediately.

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
  • use daily for 4 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Storage And Handling

Other information

  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

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

Dosage & Administration

Distributed by:

Walgreen Co.

200 Wilmot Rd.

Deerfield, IL 60015

Made in Korea

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