drug facts

drug facts
SPL v1
SPL
SPL Set ID e182eaa1-6b36-4e05-915c-c97ea3b7d833
Route
topical
Published
Effective Date 2012-08-15
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 light mineral oil stearic acid trolamine water methylparaben

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-08-01

Purpose

Antifungal

Description

Clotrimazole 1%


Medication Information

Warnings

For external use only

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

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 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

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

Inactive Ingredients

Benzyl alcohol, Carbomer 940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, methylparaben, PEG-15 glyceryl stearate, Stearic acid, Trolamine, Purified water

Description

Clotrimazole 1%

Section 51945-4

Vida Mia Clotrimazole

Active Ingredient

Clotrimazole 1%

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

Warnings

For external use only

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

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 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

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

Inactive Ingredients (Inactive ingredients)

Benzyl alcohol, Carbomer 940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, methylparaben, PEG-15 glyceryl stearate, Stearic acid, Trolamine, Purified water

Section 51945-4 (51945-4)

Vida Mia Clotrimazole

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 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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