Antifungal Athletes Foot Cream

Antifungal Athletes Foot Cream
SPL v1
SPL
SPL Set ID b6e18374-9a0f-804d-e053-2995a90a07c3
Route
TOPICAL
Published
Effective Date 2015-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Benzyl Alcohol Cetostearyl Alcohol Cetyl Esters Wax Octyldodecanol Polysorbate 60 Sorbitan Monostearate Stearyl Alcohol Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-01-31

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

Warnings

For external use only.

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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day ■ for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks ■ if conditions persist longer, ask a doctor ■ this product is not effective on the scalp or nails.

Do Not Use

children under 2 years of age unless directed by a doctor

Package Label

Active Ingredient

Clotrimazole 1%

Other Information

■  store between 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

benzyl alcohol, cetearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, stearyl alcohol, water

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 and ringworm) or 2 weeks (jock itch)

Keep Out of Reach of Children

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


Structured Label Content

Uses

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

Purpose

Antifungal

Warnings

For external use only.

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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day ■ for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks ■ if conditions persist longer, ask a doctor ■ this product is not effective on the scalp or nails.

Do Not Use (Do not use)

children under 2 years of age unless directed by a doctor

Package Label

Active Ingredient

Clotrimazole 1%

Other Information

■  store between 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

benzyl alcohol, cetearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, stearyl alcohol, water

When Using This Product (When using this product)

avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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


Advanced Ingredient Data


Raw Label Data

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