83818-022

83818-022
SPL v1
SPL
SPL Set ID 3c77222b-d92e-84b0-e063-6294a90aadd7
Route
topical
Published
Effective Date 2025-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1 g)
Inactive Ingredients
witch hazel propylene glycol dimethicone triethanolamine camphor (synthetic) arctotheca calendula whole melaleuca alternifolia (tea tree) leaf oil white wax gentian violet methylparaben menthol aloe vera leaf bis(2-chloroethyl)ether

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-16

Purpose

Antifungal

Description

Clotrimazole 1%


Medication Information

Warnings

For external use only. Do not use on children under 2 years of age unless directed by a doctor.

Purpose

Antifungal

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

Other Information

Store between 68 to 77 F (20 to 25 C)

Inactive Ingredients

Water, Camphor (Synthetic), Gentian, Glycerin, Methylparaben, Menthol, Propylene Glycol, Dimethicone, Triethanolamine, Beeswax, Tea Tree Oil, Aloe Vera, Witch Hazel, Chamomile, Calendula

Description

Clotrimazole 1%

Principal Display Panel

Use

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

Do Not Use

on children under 2 years of age unless directed by a doctor.

Active Ingredient

Clotrimazole 1%

Questions Or Comments?

Contact us at [email protected]

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

irritation occurs; there is no improvement within 4 weeks

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only. Do not use on children under 2 years of age unless directed by a doctor.

Purpose

Antifungal

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

Other Information (Other information)

Store between 68 to 77 F (20 to 25 C)

Inactive Ingredients (Inactive ingredients)

Water, Camphor (Synthetic), Gentian, Glycerin, Methylparaben, Menthol, Propylene Glycol, Dimethicone, Triethanolamine, Beeswax, Tea Tree Oil, Aloe Vera, Witch Hazel, Chamomile, Calendula

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

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

Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor.

Active Ingredient

Clotrimazole 1%

Questions Or Comments? (Questions or comments?)

Contact us at [email protected]

When Using This Product (When Using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation occurs; there is no improvement within 4 weeks

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.


Advanced Ingredient Data


Raw Label Data

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