Western Family®

SPL v1

SPL

SPL Set ID 973dfacf-9398-4880-a12a-7c83e4f1c820

Route

TOPICAL

Published

Effective Date 2013-03-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Clotrimazole (10 mg)

Inactive Ingredients

Benzyl Alcohol Cetostearyl Alcohol Cetyl Esters Wax Octyldodecanol Polysorbate 60 Water Sorbitan Monostearate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 1993-08-31

Description

Drug Facts

Purpose

Antifungal

Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses

cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
for effective relief of
- itching
- scaling
- cracking
- burning
- redness
- soreness
- irritation
- discomfort

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.

Warnings

For external use only

Directions

This product is not effective on the scalp or nails.

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 1%

Other Information

To open: unscrew cap, use the pointed end of cap to puncture seal.
store between 2°- 30°C (36° - 86°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

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 within 2 weeks (for jock itch)

Principal Display Panel 15 G Tube Carton

Athlete's

Foot Cream

Clotrimazole Cream USP, 1%

ANTIFUNGAL CREAM

Relieves

Itching, Burning,

Scaling and Cracking

NET WT 1/2 OZ (15 g)

Structured Label Content

Uses

cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
for effective relief of
- itching
- scaling
- cracking
- burning
- redness
- soreness
- irritation
- discomfort

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.

Purpose

Antifungal

Warnings

For external use only

Directions

This product is not effective on the scalp or nails.

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 (Active ingredient)

Clotrimazole 1%

Other Information (Other information)

To open: unscrew cap, use the pointed end of cap to puncture seal.
store between 2°- 30°C (36° - 86°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

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 within 2 weeks (for jock itch)

Principal Display Panel 15 G Tube Carton (PRINCIPAL DISPLAY PANEL - 15 g Tube Carton)

Athlete's

Foot Cream

Clotrimazole Cream USP, 1%

ANTIFUNGAL CREAM

Relieves

Itching, Burning,

Scaling and Cracking

NET WT 1/2 OZ (15 g)

Advanced Ingredient Data

[{"name": "Clotrimazole", "unii": "G07GZ97H65", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL ESTERS WAX", "unii": "D072FFP9GU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTYLDODECANOL", "unii": "461N1O614Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 60", "unii": "CAL22UVI4M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOSTEARATE", "unii": "NVZ4I0H58X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) for effective relief of itching scaling cracking burning redness soreness irritation discomfort", "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 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 1%", "Other information": "To open: unscrew cap, use the pointed end of cap to puncture seal. store between 2°- 30°C (36° - 86°F) see carton or tube crimp for lot number and expiration date", "Inactive ingredients": "benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate", "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 within 2 weeks (for jock itch)", "PRINCIPAL DISPLAY PANEL - 15 g Tube Carton": "Athlete's Foot Cream Clotrimazole Cream USP, 1% ANTIFUNGAL CREAM Relieves Itching, Burning, Scaling and Cracking NET WT 1/2 OZ (15 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:36.056464 · Updated: 2026-03-14T22:53:25.926266