Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID cea1065e-4123-4a3b-aebe-4d934b9cc055
Route
TOPICAL
Published
Effective Date 2011-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 mg)
Inactive Ingredients
Benzoic Acid Camphor (synthetic) Petrolatum Salicylic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-04-28

Description

Active ingredient Clotrimazole 1.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the cure of:

athlete’s foot

jock itch

ringworm



Relieves:

itching

scaling

cracking

burning

discomfort

soreness

irritation

redness

Dosage and Administration

Directions

Adults and children 12 years of age or older:

Wash the affected area and dry thoroughly. In areas where the skin is thickened, soak in warm water to soften it first

Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.

For athlete’s foot:

Pay special attention to spaces between the toes. It is useful to apply at night on cotton balls wedged 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.

Children under 12 years: Do not use unless directed by a doctor



Description

Active ingredient Clotrimazole 1.0%

Section 44425-7

Other information

keep container tightly closed

store between 2º and 30º C (36º to 86º 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

do not use the following on the skin:

soap

alcohol

hydrogen peroxide

iodine or sulphur compounds

Section 50570-1

Do not use

on children under 12 years of age unless directed by a doctor

if pregnant

if nursing

Section 51727-6

Inactive ingredients

Benzoic acid, camphor, Chimonanthus praecox (L.) Link. flower oil, insect wax (cera chinensis), petrolatum, and salicylic acid.

Section 51945-4

HUA TUO XIAN GAO Antifungal Ointment NDC 76182-001-01  20 g (0.7 oz)

Section 53413-1

Questions or comments?

(888) 221-3496 M-F 9am-5pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

Antifungal

Section 55106-9



Active ingredient

Clotrimazole 1.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

For the cure of:

athlete’s foot

jock itch

ringworm



Relieves:

itching

scaling

cracking

burning

discomfort

soreness

irritation

redness

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age or older:

Wash the affected area and dry thoroughly. In areas where the skin is thickened, soak in warm water to soften it first

Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.

For athlete’s foot:

Pay special attention to spaces between the toes. It is useful to apply at night on cotton balls wedged 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.

Children under 12 years: Do not use unless directed by a doctor



Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep container tightly closed

store between 2º and 30º C (36º to 86º 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

do not use the following on the skin:

soap

alcohol

hydrogen peroxide

iodine or sulphur compounds

Section 50570-1 (50570-1)

Do not use

on children under 12 years of age unless directed by a doctor

if pregnant

if nursing

Section 51727-6 (51727-6)

Inactive ingredients

Benzoic acid, camphor, Chimonanthus praecox (L.) Link. flower oil, insect wax (cera chinensis), petrolatum, and salicylic acid.

Section 51945-4 (51945-4)

HUA TUO XIAN GAO Antifungal Ointment NDC 76182-001-01  20 g (0.7 oz)

Section 53413-1 (53413-1)

Questions or comments?

(888) 221-3496 M-F 9am-5pm

you may also report serious side effects to this 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

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