Clotrimazole (topical Solution) Usp, 1%

Clotrimazole (topical Solution) Usp, 1%
SPL v2
SPL
SPL Set ID cb424fa8-3ed5-45cd-b03f-64675584b34e
Route
TOPICAL
Published
Effective Date 2024-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-15

Description

Clotrimazole USP, 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole USP, 1%

Uses

Cures most

• Athlete's foot (tinea pedis)

• Jock itch (tinea cruris)

• Ringworm (tinea corporis)

Effectively relieves

• itching • cracking • burning • discomfort which can accompany these conditions.

Section 42229-5

Compare to the active ingredient in Lotrimin ® AF*

Greaseless, Nonstaining

Not for Ophthalmic use.

Keep this and all medications out of the reach of children.

TAMPER EVIDENT: This bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at the time of purchase.

*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin ®AF.

Keep this carton for important information.

Distributed by:

Puro Pharma Inc.


Poughkeepsie, NY 12601

Section 50565-1

Keep out of reach of children.

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

Warnings

For external use only.

Ask a doctor before use

• on children under 2 years of age

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 (for jock itch)

Packaging

Directions

• This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

• clean the affected area and dry thoroughly

• apply a thin layer of the product 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; change shoes and socks at least once daily.

Drug Facts

Active Ingredient

Clotrimazole USP, 1%

Other Information

• store between 15°-30°C (59°-86°F)

Inactive Ingredient

polyethylene glycol

Questions Or Comments?

Call 1-(845) 450-0141

Mon-Fri 9:00AM to 5:00PM EST


Structured Label Content

Uses

Cures most

• Athlete's foot (tinea pedis)

• Jock itch (tinea cruris)

• Ringworm (tinea corporis)

Effectively relieves

• itching • cracking • burning • discomfort which can accompany these conditions.

Section 42229-5 (42229-5)

Compare to the active ingredient in Lotrimin ® AF*

Greaseless, Nonstaining

Not for Ophthalmic use.

Keep this and all medications out of the reach of children.

TAMPER EVIDENT: This bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at the time of purchase.

*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin ®AF.

Keep this carton for important information.

Distributed by:

Puro Pharma Inc.


Poughkeepsie, NY 12601

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Purpose

Antifungal

Warnings

For external use only.

Ask a doctor before use

• on children under 2 years of age

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 (for jock itch)

Packaging

Directions

• This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

• clean the affected area and dry thoroughly

• apply a thin layer of the product 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; change shoes and socks at least once daily.

Drug Facts

Active Ingredient (Active ingredient)

Clotrimazole USP, 1%

Other Information (Other information)

• store between 15°-30°C (59°-86°F)

Inactive Ingredient (Inactive ingredient)

polyethylene glycol

Questions Or Comments? (Questions or comments?)

Call 1-(845) 450-0141

Mon-Fri 9:00AM to 5:00PM EST


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)