edens hand sanitizing wipes by Baijieyuan Biotechnology (Shandong) Co., Ltd.

edens hand sanitizing wipes by

Drug Labeling and Warnings

edens hand sanitizing wipes by is a Otc medication manufactured, distributed, or labeled by Baijieyuan Biotechnology (Shandong) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EDENS HAND SANITIZING WIPES- wipes cloth 
Baijieyuan Biotechnology (Shandong) 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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Store below 110°F (43°C)

Bronopol

Benzethonium chloride

2-Phenoxyethanol

Quaternary ammonium compounds,benzyl-C12-16-alkyldimethyl,chlorides

Butane-1,3-diol

Glycerol

Aloe extract

Pure water

Open the upper cover, open the unsealing glue, pull out the wet wipes,and close the upper cover tightly to prevent the wet wipes from drying.

Ethyl alcohol

keep out of reach of children

Disinfection
Sterilization
No Rinseing

For external use only,Keep away from heat or flame.

EDENS HAND SANITIZING WIPES 
wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55490-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	168.75 g  in 50

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BRONOPOL (UNII: 6PU1E16C9W)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
ALOE (UNII: V5VD430YW9)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55490-020-01	50 in 1 PACKET; Type 0: Not a Combination Product	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2020	12/28/2020

Labeler - Baijieyuan Biotechnology (Shandong) Co., Ltd. (554531114)

Establishment
Name	Address	ID/FEI	Business Operations
Baijieyuan Biotechnology (Shandong) Co., Ltd.		554531114	manufacture(55490-020)

Revised: 12/2020

Document Id: b781e8da-1892-0c77-e053-2995a90a4642

34390-5

Set id: a972e027-4345-a28a-e053-2995a90aa65a

Version: 2

Effective Time: 20201228

 

Baiji