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

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

Dosage and Administration

10 milligrams/gram per application

Purpose

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

Description

Clotrimazole 1%


Medication Information

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.

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.

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
Dosage and Administration

10 milligrams/gram per application

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

Description

Clotrimazole 1%

Principal Display Panel

Active Ingredient

Clotrimazole 1%

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

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.

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

Purpose (PURPOSE)

Antifungal

cures most athlete's foot, jock itch and ringworm

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

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
Dosage and Administration (DOSAGE AND ADMINISTRATION)

10 milligrams/gram per application

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Active Ingredient (ACTIVE INGREDIENT)

Clotrimazole 1%

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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