Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 0a6cb1f7-a2a2-46a2-ae63-d205318996f0
Route
TOPICAL
Published
Effective Date 2023-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Mineral Oil Methylparaben Propylparaben Water White Petrolatum Propylene Glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-01

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Uses
  • Cures most athlete's foot, jock itch and ringworm.
  • Relieves itching, burning, cracking, scaling, and discomfort
Section 51945-4

Warnings

For external use only.

Do not use onchildren under 2 years of age unless directed by a doctor.

When using this productavoid contact with eyes

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement in 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)
Directions
  • wash 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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • for atlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails
Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses
  • Cures most athlete's foot, jock itch and ringworm.
  • Relieves itching, burning, cracking, scaling, and discomfort
Section 51945-4 (51945-4)

Purpose

Antifungal

Warnings

For external use only.

Do not use onchildren under 2 years of age unless directed by a doctor.

When using this productavoid contact with eyes

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement in 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)
Directions
  • wash 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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • for atlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails
Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

Keep Out of Reach of Children (Keep out of Reach of Children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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