ANTI FUNGAL- coltrimazole liquid

Anti Fungal by

Drug Labeling and Warnings

Anti Fungal by is a Otc medication manufactured, distributed, or labeled by Guangzhou Ertiantang Pharmaceutical Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Clotrimazole  1%

Purpose

Coltrimazole 1%       Antifungal

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.

Warnings

For External Use Only.

Do Not Use

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

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.

When Use This Product

Avoid contact with the eyes.
This product is not effective on the scalp or nails.

Keep Out of Reach of Children

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

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.

Storage

Store in cool, dry place away from direct sunlight.

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

Distributed by:

Bluebird Health Company
3856 Walnut Grove Avenue
Rosemead, CA 91770-1655
Phone: (626)677-1558

Made in China

Drug Facts

INGREDIENTS AND APPEARANCE

ANTI FUNGAL 
coltrimazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71582-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
GARLIC OIL (UNII: 4WG8U28833)
OSTHOL (UNII: XH1TI1759C)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)
PHRYMA LEPTOSTACHYA WHOLE (UNII: 6G287VJM69)
PHELLODENDRON CHINENSE WHOLE (UNII: QKA3ZK8IIE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71582-001-10	1 in 1 CARTON	09/22/2017
1		300 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/22/2017

Labeler - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036)

Registrant - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Ertiantang Pharmaceutical Co.,Ltd		546747036	manufacture(71582-001)