Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b4155ea9-b2d8-4826-92ee-3f6cfdef09bf
Route
TOPICAL
Published
Effective Date 2013-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type C Cetyl Alcohol Glycerin Glyceryl Monostearate Paraffin Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-12-04

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 which accompany these conditions
Section 51945-4

Clotrimazole

Warnings

For external use only

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 a day
  • For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
  • If conditions persist longer, ask a doctor
  • This product is not effective on the scalp or nails
Do Not Use
  • on children under 2 years of age except under the advice and supervision of a doctor
Active Ingredient

Clotrimazole 1%

Other Information
  • store between 2 ° and 30 °C (36°and 86°F)

Inactive Ingredients

Benzyl alcohol, Carbomer940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Purified water, Stearic acid and Trolamine

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If
  • Irritation occursThere is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch)Do not use for diaper rash
Keep Out of Reach of Children

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


Structured Label Content

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

Clotrimazole

Purpose

Antifungal

Warnings

For external use only

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 a day
  • For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
  • If conditions persist longer, ask a doctor
  • This product is not effective on the scalp or nails
Do Not Use (Do not use)
  • on children under 2 years of age except under the advice and supervision of a doctor
Active Ingredient

Clotrimazole 1%

Other Information (Other information)
  • store between 2 ° and 30 °C (36°and 86°F)

Inactive Ingredients (Inactive ingredients)

Benzyl alcohol, Carbomer940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Purified water, Stearic acid and Trolamine

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 occursThere is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch)Do not use for diaper rash
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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