SPL v4
SPL
SPL Set ID d6a9755a-9ed1-4e7d-8e73-25c169d6c6b1
Route
TOPICAL
Published
Effective Date 2023-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Butylated Hydroxytoluene Alcohol Cetostearyl Alcohol Dimethyl Sulfoxide Edetate Disodium Ethylparaben Glycerin Mineral Oil Glyceryl Mono And Dipalmitostearate Petrolatum Glycereth-31 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-03

Description

Clotrimazole USP 1% w/w

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole USP 1% w/w

Uses
  • Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
Section 50565-1

Warnings
  • For external use only
  • Do Not Use – On children under 2 years of age unless directed by a doctor.
  • 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 or ringworm) or within 2 weeks (for jock itch).
  • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
Directions
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer 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 the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Questions?

304-742-2433

Product Label

Other Information
  • Store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Close cap tightly after use.
Active Ingredients

Clotrimazole USP 1% w/w

Inactive Ingredients

Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides,Petrolatum, Polyoxyethylene lauryl ether, Purified water.


Structured Label Content

Uses
  • Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
Section 50565-1 (50565-1)

Purpose

Antifungal

Warnings
  • For external use only
  • Do Not Use – On children under 2 years of age unless directed by a doctor.
  • 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 or ringworm) or within 2 weeks (for jock itch).
  • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
Directions
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer 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 the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Questions?

304-742-2433

Product Label (Product label)

Other Information (Other information)
  • Store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Close cap tightly after use.
Active Ingredients (Active ingredients)

Clotrimazole USP 1% w/w

Inactive Ingredients (Inactive ingredients)

Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides,Petrolatum, Polyoxyethylene lauryl ether, Purified water.


Advanced Ingredient Data


Raw Label Data

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