Clotrimazole Solution
FDA Label NDC 50268-044

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avpak for the product Clotrimazole (NDC 50268-044). 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, ask a doctor before 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Before Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredient

→ Information For Owners/caregivers

→ Principal Display Panel - 30 Ml Bottle Carton

→ Principal Display Panel

Other

Clotrimazole USP, 1%

(Topical Solution)

Active Ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

Cures most

Athlete's foot (tinea pedis)
Jock Itch (tinea cruris)
Ringworm (tinea corporis)

Effectively relieves

Itching
Cracking
Burning
Discomfort which can accompany these conditions

Warnings

For external use only

Ask A Doctor Before Use

on children under 2 years of age

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)

KEEP OUT OF THE REACH OF CHILDREN.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

This product is not effective on the scalp or nails For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
clean the affected area and dry thoroughly
apply a thin layer of the product 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; change shoes and socks at least once daily