PURUS ANTIBACTERIAL WIPES- glyceryl laurate, levulinic acid, caprylhydroxamic acid, alcohol cloth

Purus antibacterial wipes by

Drug Labeling and Warnings

Purus antibacterial wipes by is a Otc medication manufactured, distributed, or labeled by The fab Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

glyceryl laurate, laurylpyridinium chloride, caprylhydroxamic acid, alcohol, levulinic acid

INACTIVE INGREDIENT

sodium coco pg-dimonium chloride phosphate, sodiu levulinate, methyl propanediol, water

PURPOSE

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

WARNINGS

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURUS ANTIBACTERIAL WIPES 
glyceryl laurate, levulinic acid, caprylhydroxamic acid, alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77504-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERYL LAURATE (UNII: Y98611C087) (GLYCERYL LAURATE - UNII:Y98611C087)	GLYCERYL LAURATE	0.0448 g  in 56 g
LEVULINIC ACID (UNII: RYX5QG61EI) (LEVULINIC ACID - UNII:RYX5QG61EI)	LEVULINIC ACID	0.028 g  in 56 g
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) (CAPRYLHYDROXAMIC ACID - UNII:UPY805K99W)	CAPRYLHYDROXAMIC ACID	0.0112 g  in 56 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.0112 mL  in 56 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77504-0004-1	56 g in 1 PACKAGE; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020

Labeler - The fab Korea Co., Ltd. (694885775)

Registrant - The fab Korea Co., Ltd. (694885775)

Establishment
Name	Address	ID/FEI	Business Operations
The fab Korea Co., Ltd.		694885775	manufacture(77504-0004)