Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8ced8bb8-adbc-419f-bc50-9c99854d08a2
Route
TOPICAL
Published
Effective Date 2014-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Yellow Wax Cetostearyl Alcohol Edetate Disodium Glyceryl Stearate Se Methylparaben Mineral Oil Petrolatum Polysorbate 60 Propylene Glycol Propylparaben Sorbitan Monostearate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-06-15

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) or as directed by a doctor ■ 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

■ on children under 2 years of age except under the advise and supervision of a doctor ■ for diaper rash

Package Label

Active Ingredient

Clotrimazole 1%

Other Information

■  store at 68 to 77F (20 to 25C)

Inactive Ingredients

Beeswax, Cetearyl Alcohol, Disodium Edta, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Stearate, Triethanolamine

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) or as directed by a doctor ■ 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)

■ on children under 2 years of age except under the advise and supervision of a doctor ■ for diaper rash

Package Label

Active Ingredient

Clotrimazole 1%

Other Information

■  store at 68 to 77F (20 to 25C)

Inactive Ingredients

Beeswax, Cetearyl Alcohol, Disodium Edta, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Stearate, Triethanolamine

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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