85248-036

85248-036
SPL v1
SPL
SPL Set ID 49ab5abb-d311-505d-e063-6294a90a5616
Route
TOPICAL
Published
Effective Date 2026-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Glycerin Propylene Glycol Methylparaben Peppermint Triethanolamine Gentiana Manshurica Root Dimethicone Camphor (synthetic)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-31

Description

Clotrimazole 1%

Purpose

Antifunga


Medication Information

Purpose

Antifunga

Description

Clotrimazole 1%

Use

·cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. ·cures most jock itch and ringworm ·relieves itching.burning, cracking, and scaling which accompany these conditions

Stop Use

too much irritation occurs or irritation gets worse

Warnings

For external use only

Ask Doctor

for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor wash hands after each use children under 12 years: ask a doctor

Directions

·adults and children 12 years and older: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot between the toes:apply to affected skin between and around the toes twice a day for 1 week(morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.

for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor wash hands after each use children under 12 years: ask a doctor

Do Not Use

·on nails or scalp ·in or near the mouth or the eyes ·for vaginal yeast infections

When Using

do not get into the eyes. lf eye contact occurs, rinse thoroughly with water

Active Ingredient

Clotrimazole 1%

Other Information

do not use if seal on tube is broken or not visible store between 20° to 25°℃(68° to 77°F)

Inactive Ingredients

Camphor (SYNTHETIC).Gentana.Glycerin.Methylparaben,Peppermint, Propylene Glycol, Silicone Oil, Triethanolamine

Principal Display Panel

Keep Oot of Reach of Children

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


Structured Label Content

Use

·cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. ·cures most jock itch and ringworm ·relieves itching.burning, cracking, and scaling which accompany these conditions

Purpose

Antifunga

Stop Use

too much irritation occurs or irritation gets worse

Warnings

For external use only

Ask Doctor

for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor wash hands after each use children under 12 years: ask a doctor

Directions

·adults and children 12 years and older: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot between the toes:apply to affected skin between and around the toes twice a day for 1 week(morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.

for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor wash hands after each use children under 12 years: ask a doctor

Do Not Use (Do not use)

·on nails or scalp ·in or near the mouth or the eyes ·for vaginal yeast infections

When Using

do not get into the eyes. lf eye contact occurs, rinse thoroughly with water

Active Ingredient

Clotrimazole 1%

Other Information (Other information)

do not use if seal on tube is broken or not visible store between 20° to 25°℃(68° to 77°F)

Inactive Ingredients (Inactive ingredients)

Camphor (SYNTHETIC).Gentana.Glycerin.Methylparaben,Peppermint, Propylene Glycol, Silicone Oil, Triethanolamine

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

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