ANTIBACTERIAL HAND WIPES- wipes cloth 
Osike Cosmetics 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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79866-005
Antibacterial Hand Wipes

Active Ingredient(s)

Benzalkonium Chloride 0.12%

Purpose

Antimicroblal

Use

●Hand sanitizer to help reduce bacteria
●For use when soap and water are not available.

Warnings

For external use only.

Do not use

●on children less than 2 months old.
●on open skin wounds

When using this product do not get in eyes. If

contact is made rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

●Apply to hands, allow to air dry without wiping.
●Children under 6 years of age should be supervised when using this product

Other information

●Store in a cool,dry place.
●Avoid freezing and excessive heat.

Inactive ingredients

Glycerin, Phenoxyethanol, Propylene Glycol, Water

800 wipes

800 wipes

1600 wipes

1600 wipes

ANTIBACTERIAL HAND WIPES 
wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79866-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79866-005-01800 in 1 BAG; Type 0: Not a Combination Product03/30/2020
2NDC:79866-005-021600 in 1 BAG; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Osike Cosmetics Co., Ltd. (415803943)
Establishment
NameAddressID/FEIBusiness Operations
Osike Cosmetics Co., Ltd.415803943manufacture(79866-005)

Revised: 11/2022
Document Id: ee99b49b-ef93-7f91-e053-2995a90afa6d
Set id: ab7d6744-9a49-65e6-e053-2995a90a5165
Version: 4
Effective Time: 20221129
 
Osike Cosmetics Co., Ltd.