Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID c62fbf23-5d19-44ab-9c1a-e9b803192ed0
Route
TOPICAL
Published
Effective Date 2023-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Yellow Wax Coconut Oil Cottonseed Oil Jojoba Oil Magnesium Oxide Palm Oil Peppermint Oil Silver Stearate Tea Tree Oil Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-30

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Uses

Proven clinically effective in the treatment of jock itch (tinea cruris). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Section 50565-1

Warnings

For external use only.  Do not use onchildren under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a physician. Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product.

Questions?

401-432-7750 or www.aidance.com

Product Label

Active Ingredient

Clotrimazole 1%

Other Information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, silver stearate, tea tree oil, zinc oxide


Structured Label Content

Uses

Proven clinically effective in the treatment of jock itch (tinea cruris). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Section 50565-1 (50565-1)

Purpose

Antifungal

Warnings

For external use only.  Do not use onchildren under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a physician. Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product.

Questions?

401-432-7750 or www.aidance.com

Product Label (Product label)

Active Ingredient

Clotrimazole 1%

Other Information (Other information)

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, silver stearate, tea tree oil, zinc oxide


Advanced Ingredient Data


Raw Label Data

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