Clotrimazole Cream Usp,1%

Clotrimazole Cream Usp,1%
SPL v2
SPL
SPL Set ID b69db78b-5f10-8ca2-e053-2a95a90ac88c
Route
TOPICAL
Published
Effective Date 2020-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Benzyl Alcohol Cetostearyl Alcohol Cetyl Esters Wax Polysorbate 60 Water Sorbitan Monostearate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 1995-06-01

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • 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.

Section 50566-9

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Section 50567-7

When using this product

  • avoid contact with eyes
Section 50569-3

Ask a doctor before use

  • on children under 2 years of age
Warnings

For external use only

Directions

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. 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

For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily

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 2°- 30°C (36° - 86°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

Principal Display Panel 15 G Carton


Structured Label Content

Uses
  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • 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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
Section 50569-3 (50569-3)

Ask a doctor before use

  • on children under 2 years of age
Purpose

Antifungal

Warnings

For external use only

Directions

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. 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

For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily

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 2°- 30°C (36° - 86°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

Principal Display Panel 15 G Carton (PRINCIPAL DISPLAY PANEL - 15 g Carton)


Advanced Ingredient Data


Raw Label Data

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