SPL v2
SPL
SPL Set ID 7e1a25b2-8414-450d-b9da-e624a1feda05
Route
TOPICAL
Published
Effective Date 2024-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Aloe Vera Leaf Benzyl Alcohol Cetostearyl Alcohol Cetyl Esters Wax Octyldodecanol Polysorbate 60 Sorbitan Monostearate .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-15

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Uses
  • Cures most athlete's foot, jock itch and ringworm
  • Relieves the itching, burning, scaling, chafing and discomfort associated with these conditions
Warnings

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

When using this product avoid contact with eyes.

Stop use and consult a doctor if

  • irritation occurs
  • if there is not improvement within 2 weeks
Directions
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer of this product over affected area twice daily (morning and night)
  • Supervise children in the use of this product.
  • use daily for 2 weeks.
  • If conditions persist longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Drug Facts

Active Ingredient

Clotrimazole 1%

Other Information 
  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Close cap tightly after use.
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetyl Esters, Octyldodecanol, Polysorbate 60, Sorbitan Monostearate, Tocopheryl Acetate, Water (purified).

Principal Display Panel 

Publix Athletes Foot Cream      NDC#  56062-817-28

1% Clotrimazole Cream

 Cures Most athlete's foot

NET WT 1 OZ (28g)

Keep Out of the Reach of Children

if swallowed, get medical help or contact a poison control center right away.

Questions Or Comments? Call 1888 267 3037


Structured Label Content

Uses
  • Cures most athlete's foot, jock itch and ringworm
  • Relieves the itching, burning, scaling, chafing and discomfort associated with these conditions
Purpose

Antifungal

Warnings

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

When using this product avoid contact with eyes.

Stop use and consult a doctor if

  • irritation occurs
  • if there is not improvement within 2 weeks
Directions
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer of this product over affected area twice daily (morning and night)
  • Supervise children in the use of this product.
  • use daily for 2 weeks.
  • If conditions persist longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Drug Facts

Active Ingredient (Active ingredient)

Clotrimazole 1%

Other Information  (Other information )
  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Close cap tightly after use.
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetyl Esters, Octyldodecanol, Polysorbate 60, Sorbitan Monostearate, Tocopheryl Acetate, Water (purified).

Principal Display Panel  (Principal Display panel )

Publix Athletes Foot Cream      NDC#  56062-817-28

1% Clotrimazole Cream

 Cures Most athlete's foot

NET WT 1 OZ (28g)

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

if swallowed, get medical help or contact a poison control center right away.

Questions Or Comments? Call 1888 267 3037 (Questions or Comments? call 1888-267-3037)


Advanced Ingredient Data


Raw Label Data

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