clotrimazole topical solution usp, 1%

SPL v3

SPL

SPL Set ID 2c60e631-5930-4420-886d-eb1990c720b6

Route

topical

Published

Effective Date 2024-11-25

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 2024-11-21

Purpose

Antifungal

Description

Drug Facts

Medication Information

Warnings

For external use only

Uses

cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
effectively relieves
- itching
- cracking
- burning
- discomfort which can accompany these conditions

Purpose

Antifungal

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

Other Information

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Inactive Ingredients

polyethylene glycol 400

Description

Drug Facts

Questions?

Call 1-866-923-4914

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Clotrimazole USP, 1%

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)

Principal Display Panel 10 Ml Bottle Carton

Rugby ^®

NDC 0536-1443-70

Compare to the

active ingredient in

Lotrimin ^®AF*

Clotrimazole Antifungal

Clotrimazole

Topical Solution

USP, 1%

Antifungal

Cures Most

Athlete's Foot

Relieves Itching, Burning
Greaseless, Nonstaining

10 mL (⅓ fl oz)

Structured Label Content

Warnings

For external use only

Uses

cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
effectively relieves
- itching
- cracking
- burning
- discomfort which can accompany these conditions

Purpose

Antifungal

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

Other Information (Other information)

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Inactive Ingredients (Inactive ingredients)

polyethylene glycol 400

Questions?

Call 1-866-923-4914

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (Active ingredient)

Clotrimazole USP, 1%

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)

Principal Display Panel 10 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton)

Rugby ^®

NDC 0536-1443-70

Compare to the

active ingredient in

Lotrimin ^®AF*

Clotrimazole Antifungal

Clotrimazole

Topical Solution

USP, 1%

Antifungal

Cures Most

Athlete's Foot

Relieves Itching, Burning
Greaseless, Nonstaining

10 mL (⅓ fl oz)

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOTRIMAZOLE", "unii": "G07GZ97H65", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) effectively relieves itching cracking burning discomfort which can accompany these conditions", "42229-5": "Drug Facts", "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", "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?": "Call 1-866-923-4914", "Active ingredient": "Clotrimazole USP, 1%", "Other information": "Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].", "Inactive ingredients": "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)", "PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton": "Rugby ® NDC 0536-1443-70 Compare to the active ingredient in Lotrimin ® AF* Clotrimazole Antifungal Clotrimazole Topical Solution USP, 1% Antifungal Cures Most Athlete's Foot Relieves Itching, Burning Greaseless, Nonstaining 10 mL (⅓ fl oz)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.131144 · Updated: 2026-03-14T23:09:16.713853