SPL v4
SPL
SPL Set ID b0e9fc77-6d5c-2472-e053-2995a90a3de4
Route
TOPICAL
Published
Effective Date 2021-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Cetostearyl Alcohol Propylene Glycol Edetate Disodium Ceteareth-12 Methylparaben Stearic Acid .alpha.-tocopherol Mineral Oil Sodium Cetostearyl Sulfate Trolamine Water Propylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

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 51945-4

original strenghth

Antifungal cream

Warnings

For external use only

Do Not Use

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

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
For Questions:

www.drspharmacyusa.com

Active Ingredient

Clotrimazole 1%

Other Information

  • store at controlled room temperature 59°-86°F (15°-30°C).
  • before using any medication, read all label directions. Keep carton, it contains important information
Inactive Ingredients

sodium cetostearyl sulfate, cetostearyl alcohol, stearic acid, trolamine, mineral oil , ceteareth-12, propylene glycol, methyl parabeen, propyl paraben, EDTA disodium, vitamin E, water

When Using This Product

avoid contact with the eyes

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask Your Doctor If:

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

Structured Label Content

Uses (USES)

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Section 51945-4 (51945-4)

original strenghth

Antifungal cream

Purpose (PURPOSE)

Antifungal

Warnings (warnings)

For external use only

Do Not Use (Do not use)

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

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
For Questions:

www.drspharmacyusa.com

Active Ingredient (ACTIVE INGREDIENT)

Clotrimazole 1%

Other Information (Other information)

  • store at controlled room temperature 59°-86°F (15°-30°C).
  • before using any medication, read all label directions. Keep carton, it contains important information
Inactive Ingredients (Inactive ingredients)

sodium cetostearyl sulfate, cetostearyl alcohol, stearic acid, trolamine, mineral oil , ceteareth-12, propylene glycol, methyl parabeen, propyl paraben, EDTA disodium, vitamin E, water

When Using This Product (WHEN USING THIS PRODUCT)

avoid contact with the eyes

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask Your Doctor If: (Stop use and ask your doctor if:)

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

Advanced Ingredient Data


Raw Label Data

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