Live Better

Live Better
SPL v3
SPL
SPL Set ID 7b2e44b9-b1ac-48c8-994d-4e9682ec8bad
Route
TOPICAL
Published
Effective Date 2013-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Cetyl Esters Wax Octyldodecanol Polysorbate 60 Water Sorbitan Monostearate Benzyl Alcohol Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1993-08-31

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

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

DISTRIBUTED BY ONPOINT, INC.

2 PARAGON DRIVE,

MONTVALE, NJ 07645

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 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 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 1-866-923-4914

Active Ingredient

Clotrimazole 1%

Other Information
  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20°- 25°C (68° - 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 14.2 G Tube Carton

Antifungal Cream

CLOTRIMAZOLE CREAM USP, 1%

■ CURES MOST ATHLETE'S FOOT ■ ANTIFUNGAL

NET WT (1/2 oz) 14.2g


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)

DISTRIBUTED BY ONPOINT, INC.

2 PARAGON DRIVE,

MONTVALE, NJ 07645

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 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 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 1-866-923-4914

Active Ingredient (Active ingredient)

Clotrimazole 1%

Other Information (Other information)
  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20°- 25°C (68° - 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 14.2 G Tube Carton (PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton)

Antifungal Cream

CLOTRIMAZOLE CREAM USP, 1%

■ CURES MOST ATHLETE'S FOOT ■ ANTIFUNGAL

NET WT (1/2 oz) 14.2g


Advanced Ingredient Data


Raw Label Data

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