Clotrimazole Usp, 1%

Clotrimazole Usp, 1%
SPL v3
SPL
SPL Set ID 9aba1345-ef47-4951-8448-a43d6696b616
Route
TOPICAL
Published
Effective Date 2023-06-19
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 Sorbitan Monostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-14

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this productavoid contact with the eyes.

Section 50570-1

Do not useon children under 2 years of age unless directed by a doctor.

Warnings

For external use only

Directions
  • wash 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 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, ask a doctor
  • this product is not effective on the scalp or nails
Questions?

call 833-358-6431

Active Ingredient

Clotrimazole 1%

Other Information
  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • to open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).
Principal Display Panel 30 G Tube Carton

Foster & Thrive™

Athlete's Foot Cream

Clotrimazole Cream USP, 1%

ANTIFUNGAL

NET WT 1 OZ (30 g)


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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this productavoid contact with the eyes.

Section 50570-1 (50570-1)

Do not useon children under 2 years of age unless directed by a doctor.

Purpose

Antifungal

Warnings

For external use only

Directions
  • wash 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 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, ask a doctor
  • this product is not effective on the scalp or nails
Questions?

call 833-358-6431

Active Ingredient (Active ingredient)

Clotrimazole 1%

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • to open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

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 or ringworm) or 2 weeks (for jock itch).
Principal Display Panel 30 G Tube Carton (PRINCIPAL DISPLAY PANEL - 30 g Tube Carton)

Foster & Thrive™

Athlete's Foot Cream

Clotrimazole Cream USP, 1%

ANTIFUNGAL

NET WT 1 OZ (30 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)