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

Purpose

Antifungal

Description

Clotrimazole 1%


Medication Information

Warnings

For external use only

Uses
  • Cures most athlete's foot, jock itch, and ringworm
  • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Purpose

Antifungal

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
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

Description

Clotrimazole 1%

Section 51945-4

Clotrimazole

Do Not Use
  • on children under 2 years of age except under the advice and supervision of a doctor
Active Ingredient

Clotrimazole 1%

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

Warnings

For external use only

Uses
  • Cures most athlete's foot, jock itch, and ringworm
  • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Purpose

Antifungal

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
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

Section 51945-4 (51945-4)

Clotrimazole

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%

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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