The fab Korea Co., Ltd. - Purus antibacterial wipes

PURUS ANTIBACTERIAL WIPES- glyceryl laurate, levulinic acid, caprylhydroxamic acid, alcohol cloth
The fab Korea 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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glyceryl laurate, laurylpyridinium chloride, caprylhydroxamic acid, alcohol, levulinic acid

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

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 the children

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.

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.

for external use only

label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

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

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

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