Clotrimazole 1% Topical Antifungal Cream

Clotrimazole 1% Topical Antifungal Cream
SPL v6
SPL
SPL Set ID b3b83f3f-9349-fb75-e053-2995a90acb65
Route
TOPICAL
Published
Effective Date 2020-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Benzyl Alcohol Water Polysorbate 60

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-21

Description

Clotrimazole 1%

Indications and Usage

Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night). Children under 2 years of age: consult a doctor

Purpose

Antifungal cures most athlete's foot, jock itch and ringworm relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Dosage and Administration

10 milligrams/gram per application


Medication Information

Indications and Usage

Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).

Children under 2 years of age: consult a doctor

Purpose

Antifungal

cures most athlete's foot, jock itch and ringworm

relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Dosage and Administration

10 milligrams/gram per application

Description

Clotrimazole 1%

Warnings

For external use only

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 ask a doctor if

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

Keep out of reach of children.

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

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to the spaces between the toes, wear well fitting, ventilated shoes and change 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 persists longer, ask a doctor
  • this product is not effective on the scalp or nails
Active Ingredient

Clotrimazole 1%

Other Information
  • To open: unscrew cap, remove liner seal and replace cap
  • Store at USP controlled room temperature 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

Principal Display Panel

Stop Use and Ask Doctor If

irritation occurs

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

Keep Out of Reach of Children

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


Structured Label Content

Purpose (PURPOSE)

Antifungal

cures most athlete's foot, jock itch and ringworm

relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Warnings (WARNINGS)

For external use only

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 ask a doctor if

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

Keep out of reach of children.

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

Directions (DIRECTIONS)
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to the spaces between the toes, wear well fitting, ventilated shoes and change 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 persists longer, ask a doctor
  • this product is not effective on the scalp or nails
Active Ingredient (ACTIVE INGREDIENT)

Clotrimazole 1%

Other Information (OTHER INFORMATION)
  • To open: unscrew cap, remove liner seal and replace cap
  • Store at USP controlled room temperature 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

Indications and Usage (INDICATIONS AND USAGE)

Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).

Children under 2 years of age: consult a doctor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dosage and Administration (DOSAGE AND ADMINISTRATION)

10 milligrams/gram per application

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

irritation occurs

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

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


Advanced Ingredient Data


Raw Label Data

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