Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 3a262bcd-e6c0-4554-ab1c-9c861f90e190
Route
TOPICAL
Published
Effective Date 2018-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Glycerin Isopropyl Alcohol Musk Xylene Phenol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-11-26 Until 2029-08-30

Description

Active Ingredient Clotrimazole 1.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable

Keep away from fire or flame.

Indications and Usage

Uses

Proven clinically effective in the treatment of most:

athlete’s foot

jock itch

ringworm

Dosage and Administration

Directions

Wash the affected area and dry thoroughly.

Apply a thin layer of the product over the 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.

For athlete’s foot and ringworm: use daily for 4 weeks.

For jock itch: use daily for 2 weeks.

If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

Description

Active Ingredient Clotrimazole 1.0%

Section 44425-7

Other Information

Keep container tightly closed, away from heat

Store at 2° to 30° C (36° to 86° F)

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

irritation occurs

there is no improvement within:

     2 weeks when used for jock itch

     4 weeks when used for athlete’s foot or ringworm

Section 50567-7

When using this product avoid contact with the eyes.

Section 50570-1

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

Section 51727-6

Inactive Ingredients

Glycerin, isopropyl alcohol, musk xylol, phenol and purified water.

Section 51945-4

AU KAH CHUEN ANTIFUNGAL LOTION

NDC 72030-100-01

0.81 fl oz (24 mL)

Section 53413-1

Questions or Comments? (888) 221-3496 M-F, 9am to 5pm

you may also report serious side effects to the phone number.

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active Ingredient

Clotrimazole 1.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

Proven clinically effective in the treatment of most:

athlete’s foot

jock itch

ringworm

Dosage and Administration (34068-7)

Directions

Wash the affected area and dry thoroughly.

Apply a thin layer of the product over the 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.

For athlete’s foot and ringworm: use daily for 4 weeks.

For jock itch: use daily for 2 weeks.

If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable

Keep away from fire or flame.

Section 44425-7 (44425-7)

Other Information

Keep container tightly closed, away from heat

Store at 2° to 30° C (36° to 86° F)

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 50566-9 (50566-9)

Stop use and ask a doctor if

irritation occurs

there is no improvement within:

     2 weeks when used for jock itch

     4 weeks when used for athlete’s foot or ringworm

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients

Glycerin, isopropyl alcohol, musk xylol, phenol and purified water.

Section 51945-4 (51945-4)

AU KAH CHUEN ANTIFUNGAL LOTION

NDC 72030-100-01

0.81 fl oz (24 mL)

Section 53413-1 (53413-1)

Questions or Comments? (888) 221-3496 M-F, 9am to 5pm

you may also report serious side effects to the phone number.

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active Ingredient

Clotrimazole 1.0%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)