Athlete's Foot Solution

Athlete's Foot Solution
SPL v3
SPL
SPL Set ID 1280353c-9f96-557e-e063-6294a90a10f9
Route
TOPICAL
Published
Effective Date 2024-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-22

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.

Warnings

For external use only.

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.
Active Ingredient

Clotrimazole USP, 1%

Other Information
  • store between 15º-30ºC (59º-86ºF)
Inactive Ingredient

polyethylene glycol

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

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)

Keep Out of Reach of Children.

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

Principal Display Panel Container Label

NDC 70010- 229-54

Clotrimazole

(Topical Solution), USP

1%

Antifungal

For External use only,

not for Opthalmic use.

Keep this and all medications out

of the reach of children.

10 mL (1/3 fl oz)

Principal Display Panel Container Carton Label

NDC 70010- 229-54

*Compare to the active ingredient in

Lotrimin ® AF

Athlete's Foot Solution

Clotrimazole

(Topical Solution),

USP

1%

Antifungal

• Relieves Itching & Burning

• Greaseless, Nonstanining

For External use only,

Not for Ophthalmic use.

Keep this and all medications

out of the reach of children.

10 mL (1/3 fl oz)


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.

Purpose

Antifungal

Warnings

For external use only.

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.
Active Ingredient (Active ingredient)

Clotrimazole USP, 1%

Other Information (Other information)
  • store between 15º-30ºC (59º-86ºF)
Inactive Ingredient (Inactive ingredient)

polyethylene glycol

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Ask A Doctor Before Use (Ask a doctor before use)

• on children under 2 years of age

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 (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.

Principal Display Panel Container Label (PRINCIPAL DISPLAY PANEL - Container Label)

NDC 70010- 229-54

Clotrimazole

(Topical Solution), USP

1%

Antifungal

For External use only,

not for Opthalmic use.

Keep this and all medications out

of the reach of children.

10 mL (1/3 fl oz)

Principal Display Panel Container Carton Label (PRINCIPAL DISPLAY PANEL - Container Carton Label)

NDC 70010- 229-54

*Compare to the active ingredient in

Lotrimin ® AF

Athlete's Foot Solution

Clotrimazole

(Topical Solution),

USP

1%

Antifungal

• Relieves Itching & Burning

• Greaseless, Nonstanining

For External use only,

Not for Ophthalmic use.

Keep this and all medications

out of the reach of children.

10 mL (1/3 fl oz)


Advanced Ingredient Data


Raw Label Data

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