Clotrimazole Cream Usp, 1%

Clotrimazole Cream Usp, 1%
SPL v2
SPL
SPL Set ID 142c53ba-d616-434e-8fce-a79821dd5384
Route
TOPICAL
Published
Effective Date 2014-03-04
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

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 1993-08-31

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • cures most jock itch (tinea cruris)
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort
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.
Warnings

For external use only

Directions

This product is not effective on the scalp or nails.

Questions?

1-888-287-1915

For Jock Itch

use daily for 2 weeks.

  • clean 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
Active Ingredient

Clotrimazole 1%

Other Information
  • unscrew cap, pull tab to remove foil 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

Ask A Doctor Before Use
  • on children under 2 years of age
When Using This Product
  • avoid contact with eyes
Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 2 weeks (for jock itch)
Principal Display Panel 15 G Tube Carton

NDC 49035-123-07

equate ®

Compare to

Lotrimin
® AF

Active

Ingredient*

Jock Itch

Clotrimazole USP 1%

Antifungal Cream

Cures Most

Jock Itch

  • Relieves itching, burning,

    scaling and chafing

NET WT

0.5 OZ (15 g)


Structured Label Content

Uses
  • cures most jock itch (tinea cruris)
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort
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.
Purpose

Antifungal

Warnings

For external use only

Directions

This product is not effective on the scalp or nails.

Questions?

1-888-287-1915

For Jock Itch (For jock itch)

use daily for 2 weeks.

  • clean 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
Active Ingredient (Active ingredient)

Clotrimazole 1%

Other Information (Other information)
  • unscrew cap, pull tab to remove foil 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

Ask A Doctor Before Use (Ask a doctor before use)
  • on children under 2 years of age
When Using This Product (When using this product)
  • avoid contact with eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 2 weeks (for jock itch)
Principal Display Panel 15 G Tube Carton (PRINCIPAL DISPLAY PANEL - 15 g Tube Carton)

NDC 49035-123-07

equate ®

Compare to

Lotrimin
® AF

Active

Ingredient*

Jock Itch

Clotrimazole USP 1%

Antifungal Cream

Cures Most

Jock Itch

  • Relieves itching, burning,

    scaling and chafing

NET WT

0.5 OZ (15 g)


Advanced Ingredient Data


Raw Label Data

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