perrigo clotrimazole cream usp, 1% drug facts

perrigo clotrimazole cream usp, 1% drug facts
SPL v7
SPL
SPL Set ID eeb241a3-93ee-4b74-8cbb-65713d15e7e0
Route
topical
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1 g)
Inactive Ingredients
benzyl alcohol cetostearyl alcohol cetyl esters wax octyldodecanol polysorbate 60 water sorbitan monostearate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2011-06-03

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 the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot pay special attention to the spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily
  • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
Other Information
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Description

Clotrimazole 1%

Principal Display Panel

Cures Most Athlete’s Foot

Relieves Itching & Burning

Greaseless, Non-Staining

Compare to Lotrimin® AF active ingredient

Clotrimazole Cream USP, 1%

Antifungal

NET WT 1 OZ (30 g)

Do Not Use

on children under 2 years of age unless directed by a doctor

Active Ingredient

Clotrimazole 1%

Questions Or Comments?

1-800-719-9260

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

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)
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 the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot pay special attention to the spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily
  • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Principal Display Panel

Cures Most Athlete’s Foot

Relieves Itching & Burning

Greaseless, Non-Staining

Compare to Lotrimin® AF active ingredient

Clotrimazole Cream USP, 1%

Antifungal

NET WT 1 OZ (30 g)

Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor

Active Ingredient (Active ingredient)

Clotrimazole 1%

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

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)
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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