Clotrimazole Usp, 1%

SPL v6

SPL

SPL Set ID 8731f4ca-84a0-4325-895b-35bf8e2ff0e1

Route

TOPICAL

Published

Effective Date 2023-05-25

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 DRUG Active Since 1993-08-31

Description

Drug Facts

Purpose

Antifungal

Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses

cures most athlete's foot, jock itch and ringworm
relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

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.

Section 50567-7

When using this productavoid contact with eyes.

Section 50570-1

Do not useon children under 2 years of age unless directed by a doctor.

Warnings

For external use only

Directions

wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night)
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 and change socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails

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 20° - 25°C (68° - 77°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

Stop Use and Ask A Doctor If

irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Principal Display Panel 28.4 G Tube Carton

CVS Health _®

Compare to the active

ingredient in Lotrimin ^®AF*

NDC 59779-305-02

Clotrimazole

Cream, USP, 1%

ANTIFUNGAL

Cures most athlete's foot
Relieves itching, burning,

cracking & scaling

Actual Product Size on Side Panel

NET WT 1 OZ (28.4 g)

Structured Label Content

Uses

cures most athlete's foot, jock itch and ringworm
relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

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.

Section 50567-7 (50567-7)

When using this productavoid contact with eyes.

Section 50570-1 (50570-1)

Do not useon children under 2 years of age unless directed by a doctor.

Purpose

Antifungal

Warnings

For external use only

Directions

wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night)
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 and change socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails

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 20° - 25°C (68° - 77°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

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 or ringworm) or 2 weeks (for jock itch).

Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

CVS Health _®

Compare to the active

ingredient in Lotrimin ^®AF*

NDC 59779-305-02

Clotrimazole

Cream, USP, 1%

ANTIFUNGAL

Cures most athlete's foot
Relieves itching, burning,

cracking & scaling

Actual Product Size on Side Panel

NET WT 1 OZ (28.4 g)

Advanced Ingredient Data

[{"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": ""}, {"name": "CLOTRIMAZOLE", "unii": "G07GZ97H65", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "cures most athlete's foot, jock itch and ringworm relieves itching, burning, cracking, scaling and discomfort which 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.", "50567-7": "When using this product avoid contact with eyes.", "50570-1": "Do not use on children under 2 years of age unless directed by a doctor.", "Purpose": "Antifungal", "Warnings": "For external use only", "Directions": "wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) 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 and change socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks if condition persists longer, ask a doctor this product is not effective on the scalp or nails", "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 20° - 25°C (68° - 77°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", "Stop use and ask a doctor if": "irritation occurs there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).", "PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton": "CVS Health ® Compare to the active ingredient in Lotrimin ® AF* NDC 59779-305-02 Clotrimazole Cream, USP, 1% ANTIFUNGAL Cures most athlete's foot Relieves itching, burning, cracking & scaling Actual Product Size on Side Panel NET WT 1 OZ (28.4 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.065883 · Updated: 2026-03-14T23:09:16.713853