clotrimazole vaginal cream, usp

clotrimazole vaginal cream, usp
SPL v4
SPL
SPL Set ID cdb619ea-29a3-4c17-a6ec-8ff0b2f31ab4
Route
vaginal
Published
Effective Date 2024-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (10 mg)
Inactive Ingredients
benzyl alcohol cetostearyl alcohol cetyl esters wax octyldodecanol polysorbate 60 water sodium phosphate, monobasic, monohydrate sorbitan monostearate

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2021-09-30 Until 2026-05-30

Purpose

Antifungal

Description

Clotrimazole, USP 1% )


Medication Information

Warnings

For external use only

Uses
  • treats most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, and discomfort
Purpose

Antifungal

Directions
  • wash the affected area and dry thoroughly
  • apply a thin layer of the product 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 daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails
Other Information
  • store at room temperature 20º-25ºC (68º-77ºF)
  • before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Description

Clotrimazole, USP 1% )

Principal Display Panel

COMPARE TO LOTRIMIN® AF ATHLETE'S FPPT CREAM ACTIVE INGREDIENT*

Athlete's Foot Cream

Cure Most Athlete's Foot

RELIEVES:

  • Itching
  • Burning
  • Cracking
  • Scaling
  • Proven Clinically Effective in the Treatment of Most Athlete's Foot
  • Soothes Itching and Burning

NET WT. OZ (g)

*This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Lotrimin® AF Athlete's Foot Cream.

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com

Do Not Use

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

Package Label
TOPCARE HEALTH Athlete's Foot Cream
Active Ingredients

Clotrimazole, USP 1%

)

Question Or Comments?

Call toll free 1-888-423-0139

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 foots and ringworm) or within 2 weeks (for jock itch)
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Warnings

For external use only

Uses
  • treats most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, and discomfort
Purpose

Antifungal

Directions
  • wash the affected area and dry thoroughly
  • apply a thin layer of the product 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 daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails
Other Information (Other information)
  • store at room temperature 20º-25ºC (68º-77ºF)
  • before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Principal Display Panel (Principal display panel)

COMPARE TO LOTRIMIN® AF ATHLETE'S FPPT CREAM ACTIVE INGREDIENT*

Athlete's Foot Cream

Cure Most Athlete's Foot

RELIEVES:

  • Itching
  • Burning
  • Cracking
  • Scaling
  • Proven Clinically Effective in the Treatment of Most Athlete's Foot
  • Soothes Itching and Burning

NET WT. OZ (g)

*This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Lotrimin® AF Athlete's Foot Cream.

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com

Do Not Use (Do not use)

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

Package Label (Package label)
TOPCARE HEALTH Athlete's Foot Cream
Active Ingredients (Active ingredients)

Clotrimazole, USP 1%

)

Question Or Comments? (Question or comments?)

Call toll free 1-888-423-0139

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 foots and ringworm) or within 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 (1-800-222-1222) right away.


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