Clotrimazole Topical Solution Usp,1%

SPL v6

SPL

SPL Set ID 692d7e0f-50d4-4abb-8c74-36bc98064fe7

Route

TOPICAL

Published

Effective Date 2024-09-17

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 2024-09-13

Description

Drug Facts

Purpose

Antifungal

Medication Information

Purpose

Antifungal

Description

Drug Facts

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

Drug Facts

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

Questions?

Please Call 1-877-225-6999

Active Ingredient

Clotrimazole USP, 1%

Other Information

Store at 15° to 30°C (59° to 86°F)

Inactive Ingredient

polyethylene glycol 400

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 10 Ml Bottle Carton

NDC 71399-0500-1

Compare to the active ingredient of Lotrimin ^®AF*

Clotrimazole Topical Solution USP,1%

Antifungal

Relieves Itching & Burning
Greaseless, Nonstaining

For External use only.

Not for Opthalmic use.

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

Akron Pharma

10ml

NDC 71399-0500-3

Compare to the active ingredient of Lotrimin®AF*

Clotrimazole Topical Solution USP,1%

Antifungal

Relieves Itching & Burning

Greaseless, Nonstaining

For External use only.

Not for Opthalmic use.

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

Akron Pharma

30ml

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)

Drug Facts

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

Questions?

Please Call 1-877-225-6999

Active Ingredient (Active ingredient)

Clotrimazole USP, 1%

Other Information (Other information)

Store at 15° to 30°C (59° to 86°F)

Inactive Ingredient (Inactive ingredient)

polyethylene glycol 400

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 10 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton)

NDC 71399-0500-1

Compare to the active ingredient of Lotrimin ^®AF*

Clotrimazole Topical Solution USP,1%

Antifungal

Relieves Itching & Burning
Greaseless, Nonstaining

For External use only.

Not for Opthalmic use.

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

Akron Pharma

10ml

NDC 71399-0500-3

Compare to the active ingredient of Lotrimin®AF*

Clotrimazole Topical Solution USP,1%

Antifungal

Relieves Itching & Burning

Greaseless, Nonstaining

For External use only.

Not for Opthalmic use.

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

Akron Pharma

30ml

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOTRIMAZOLE", "unii": "G07GZ97H65", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "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", "Questions?": "Please Call 1-877-225-6999", "Active ingredient": "Clotrimazole USP, 1%", "Other information": "Store at 15° to 30°C (59° to 86°F)", "Inactive ingredient": "polyethylene glycol 400", "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 - 10 mL Bottle Carton": "NDC 71399-0500-1 Compare to the active ingredient of Lotrimin ® AF* Clotrimazole Topical Solution USP,1% Antifungal Relieves Itching & Burning Greaseless, Nonstaining For External use only. Not for Opthalmic use. Keep this and all medications out of the reach of children . Akron Pharma 10ml NDC 71399-0500-3 Compare to the active ingredient of Lotrimin®AF* Clotrimazole Topical Solution USP,1% Antifungal Relieves Itching & Burning Greaseless, Nonstaining For External use only. Not for Opthalmic use. Keep this and all medications out of the reach of children. Akron Pharma 30ml"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:17.620990 · Updated: 2026-03-14T23:12:30.242816