BABY SHARK ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride cloth 
ZHEJIANG GREENFACE HOUSEWARES 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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42255-902 BABY SHARK ANTIBACTERIAL HAND SANITIZING WIPES 0.12% benzalkonium chloride

Active ingredient

Benzalkonium chloride 0.12%

Purpose

Antibacterial

Use

decreases bacteria on skin

Warnings

For external use only.

Do not use over large areas of the body

if you are allergic to any of the ingredients.

When using this product do not get into eyes.

If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash

develops and continues for more than 72 hours.
Keep out of reach of children.
If swallowed, get medical help or contact
a Poison Control Center right away.

Keep out of reach of children

if swallowed

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

Directions

For adults and children of 2 years and over use

on hands and face to clean and refresh, allow

skin to air dry.

For children under 2 years ask a doctor before use.

Water, Propylene glycol, Cocamidopropyl betaine,
Aloe barbadensis leaf extract, Tocopheryl acetate,
Polysorbate 20, Polyaminopropyl biguanide,
Phenoxyethanol, Disodium EDTA, lodopropynyI
butylcarbamate, Citric acid.

4321

BABY SHARK ANTIBACTERIAL HAND SANITIZING WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42255-902
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42255-902-0124 in 1 CARTON09/02/2020
120 in 1 BAG
14.8 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2NDC:42255-902-0224 in 1 CARTON09/02/2020
230 in 1 BAG
24.8 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3NDC:42255-902-0324 in 1 CARTON09/02/2020
340 in 1 BAG
34.8 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4NDC:42255-902-0424 in 1 CARTON09/02/2020
450 in 1 BAG
44.8 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/02/2020
Labeler - ZHEJIANG GREENFACE HOUSEWARES CO., LTD. (546596567)
Establishment
NameAddressID/FEIBusiness Operations
ZHEJIANG GREENFACE HOUSEWARES CO., LTD.527999264manufacture(42255-902)

Revised: 9/2020
Document Id: ae4da938-df09-5815-e053-2995a90a5b46
Set id: ae4db2ad-36da-8e67-e053-2995a90a70d2
Version: 1
Effective Time: 20200902
 
ZHEJIANG GREENFACE HOUSEWARES CO., LTD.