Guangzhou Ertiantang Pharmaceutical Co.,ltd

Guangzhou Ertiantang Pharmaceutical Co.,ltd
SPL v32879
SPL
SPL Set ID 1b36331a-0416-450c-81df-30780afff6c8
Route
TOPICAL
Published
Effective Date 2023-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Acetic Acid Garlic Oil Osthol Sophora Flavescens Root Pseudolarix Amabilis Bark Phryma Leptostachya Whole Phellodendron Chinense Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-22

Description

Clotrimazole  1%

Purpose

Coltrimazole 1%       Antifungal


Medication Information

Purpose

Coltrimazole 1%       Antifungal

Description

Clotrimazole  1%

Uses

• For the cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis).

• For relief of itching, scaling, burning and discomfort that accompany these conditions.

Section 42229-5

Distributed by:

Bluebird Health Company

3856 Walnut Grove Avenue

Rosemead, CA 91770-1655

Phone: (626)677-1558

Made in China

Storage

Store in cool, dry place away from direct sunlight.

Warnings

For External Use Only.

Directions

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, and 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.

Do Not Use

On children under 2 years of age unless directed by a doctor.

Drug Facts

Active Ingredients

Clotrimazole  1%

Inactive Ingredients

GLACIAL ACETIC ACID, GARLIC OIL, OSTHOL, SOPHORA FLAVESCENS ROOT, PSEUDOLARIX AMABILIS BARK,PHRYMA LEPTOSTACHYA WHOLE, PHELLODENDRON CHINENSE WHOLE

When Use This Product

• Avoid contact with the eyes.

• This product is not effective on the scalp or nails.

Stop Use and Ask A Doctor If

• Irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot).

• If irritation occurs or if there is no improvement within 4 weeks (for jock itch).

• If condition persists longer, consult a doctor.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

• For the cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis).

• For relief of itching, scaling, burning and discomfort that accompany these conditions.

Section 42229-5 (42229-5)

Distributed by:

Bluebird Health Company

3856 Walnut Grove Avenue

Rosemead, CA 91770-1655

Phone: (626)677-1558

Made in China

Purpose

Coltrimazole 1%       Antifungal

Storage

Store in cool, dry place away from direct sunlight.

Warnings

For External Use Only.

Directions

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, and 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.

Do Not Use

On children under 2 years of age unless directed by a doctor.

Drug Facts

Active Ingredients

Clotrimazole  1%

Inactive Ingredients

GLACIAL ACETIC ACID, GARLIC OIL, OSTHOL, SOPHORA FLAVESCENS ROOT, PSEUDOLARIX AMABILIS BARK,PHRYMA LEPTOSTACHYA WHOLE, PHELLODENDRON CHINENSE WHOLE

When Use This Product

• Avoid contact with the eyes.

• This product is not effective on the scalp or nails.

Stop Use and Ask A Doctor If (Stop Use and Ask a Doctor if)

• Irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot).

• If irritation occurs or if there is no improvement within 4 weeks (for jock itch).

• If condition persists longer, consult a doctor.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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