Drug Facts

Composition & Product

Active Ingredients

Clotrimazole (1 g)

Inactive Ingredients

Cetostearyl Alcohol Ethylparaben Glycerin Light Mineral Oil Propylene Glycol Sodium Sulfite Steareth-20 Stearic Acid Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-12-06

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

cures most ringworm (tinea corporis)

relieves

   itching

   scaling

   cracking

   burning

   discomfort

   soreness

   irritation

   redness

Dosage and Administration

Directions

Adults and children 2 years of age or older: 

   wash the affected area and dry thoroughly 

   apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor

   supervise children in the use of this product  use daily for 4 weeks 

   if condition persists longer, consult a doctor 

   this product is not effective on the scalp or nails

Children under 2 years: do not use unless directed by a doctor

Description

Active ingredient Clotrimazole 1.0%

Section 44425-7

Other information

keep container tightly closed 

store between 15 and 30 C (59 to 86 F)

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

Section 50567-7

When using this product

avoid contact with the eyes

Section 50570-1

Do not use

on children under 2 years of age unless directed by a doctor

Section 51727-6

Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, sodium sulfite, steareth-20, stearic acid, and water

Section 51945-4

PerfectHeal Antifungal

Clotrimazole 1%

Antifungal Cream

Net Wt. 10 g (1/3 oz)

NDC 69070-303-01

Section 53413-1

Questions or comments? (888) 221-3496 M-F 9am-5pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

Clotrimazole 1.0%

Structured Label Content

Indications and Usage (34067-9)

Uses

cures most ringworm (tinea corporis)

relieves

   itching

   scaling

   cracking

   burning

   discomfort

   soreness

   irritation

   redness

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age or older: 

   wash the affected area and dry thoroughly 

   apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor

   supervise children in the use of this product  use daily for 4 weeks 

   if condition persists longer, consult a doctor 

   this product is not effective on the scalp or nails

Children under 2 years: do not use unless directed by a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep container tightly closed 

store between 15 and 30 C (59 to 86 F)

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

Section 50567-7 (50567-7)

When using this product

avoid contact with the eyes

Section 50570-1 (50570-1)

Do not use

on children under 2 years of age unless directed by a doctor

Section 51727-6 (51727-6)

Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, sodium sulfite, steareth-20, stearic acid, and water

Section 51945-4 (51945-4)

PerfectHeal Antifungal

Clotrimazole 1%

Antifungal Cream

Net Wt. 10 g (1/3 oz)

NDC 69070-303-01

Section 53413-1 (53413-1)

Questions or comments? (888) 221-3496 M-F 9am-5pm

you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Clotrimazole 1.0%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses cures most ringworm (tinea corporis) relieves itching scaling cracking burning discomfort soreness irritation redness", "34068-7": "Directions Adults and children 2 years of age or older:  wash the affected area and dry thoroughly  apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product  use daily for 4 weeks  if condition persists longer, consult a doctor  this product is not effective on the scalp or nails Children under 2 years: do not use unless directed by a doctor", "34071-1": "Warnings For external use only", "44425-7": "Other information keep container tightly closed  store between 15 and 30 C (59 to 86 F)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if  irritation occurs  there is no improvement within 4 weeks", "50567-7": "When using this product avoid contact with the eyes", "50570-1": "Do not use on children under 2 years of age unless directed by a doctor", "51727-6": "Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, sodium sulfite, steareth-20, stearic acid, and water", "51945-4": "PerfectHeal Antifungal Clotrimazole 1% Antifungal Cream Net Wt. 10 g (1/3 oz) NDC 69070-303-01", "53413-1": "Questions or comments? (888) 221-3496 M-F 9am-5pm you may also report serious side effects to this phone number", "55105-1": "Purpose Antifungal", "55106-9": "Active ingredient Clotrimazole 1.0%"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information