clotrimazole cream-antifungal

clotrimazole cream-antifungal
SPL v2
SPL
SPL Set ID afbc28f8-bb76-424d-9d73-136e6c283ead
Route
topical
Published
Effective Date 2025-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-06

Purpose

Antifungal

Description

Clotrimazole, USP 1% 


Medication Information

Warnings

For external use only.

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 20°C to 25°C (68°F to 77°F)
  • 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

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 0.5 OZ (14 g)

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 1 OZ (28 g)

Use(s)
  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, and discomfort


Do Not Use

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

Active Ingredient(s)

Clotrimazole, USP 1% 

Questions Or Comments?

Call 1-833-285-4151

When Using This Product

avoid contact with the eyes.

Stop Use and Ask Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot 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 (WARNINGS)

For external use only.

Purpose (PURPOSE)

Antifungal

Directions (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 20°C to 25°C (68°F to 77°F)
  • 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)

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 0.5 OZ (14 g)

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 1 OZ (28 g)

Use(s) (USE(S))
  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, and discomfort


Do Not Use (DO NOT USE)

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

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Clotrimazole, USP 1% 

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-833-285-4151

When Using This Product (WHEN USING THIS PRODUCT)

avoid contact with the eyes.

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot 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.


Advanced Ingredient Data


Raw Label Data

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