Guangzhou Ertiantang Pharmaceutical Co.,Ltd

Guangzhou Ertiantang Pharmaceutical Co.,Ltd

Drug Labeling and Warnings

Drug Details

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ANTI FUNGAL- coltrimazole liquid 
Guangzhou Ertiantang Pharmaceutical Co.,Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Guangzhou Ertiantang Pharmaceutical Co.,Ltd

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

Distributed by:

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

Made in China

Drug Facts

image description

ANTI FUNGAL 
coltrimazole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71582-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71582-001-101 in 1 CARTON09/22/2017
1300 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/22/2017
Labeler - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036)
Registrant - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Ertiantang Pharmaceutical Co.,Ltd546747036manufacture(71582-001)

Revised: 8/2017
 
Guangzhou Ertiantang Pharmaceutical Co.,Ltd


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