Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 19ed56cd-e951-57b6-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Benzyl Alcohol Carbomer 940 Cetyl Alcohol Glycerin Glyceryl Monostearate Paraffin Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-02

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

Lakesia

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer cover 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

Active Ingredient

Clotrimazole 1%

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

Inactive Ingredients

Benzyl alcohol, Carbomer940, Cetyl alcohol, Glycerin, Clyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Trolamine, Purified water

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If
  • irritation occurs
  • there 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)

Lakesia

Purpose

Antifungal

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer cover 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

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, Clyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Trolamine, Purified water

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 occurs
  • there 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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