ALCOHOL DISINFECTANT WIPES- alcohol disinfectant wipes cloth 
Zhejiang Huanghua Biological Technology 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 in a cool dry place away from heat, direct sunlight, or flames.

pure water

Lift lid, remove adhesive strip, and pull out a wipe.Thoroughly wipe to clean.After use, close lid to prevent the wipes from drying out.

alcohol

Benzalkamine

2-methyl-4-isothiazoline-3-one

propylene glyco

2-phenoxyethanol

ln or near the eyes.
On open skin wounds or burns.

Keep out of the reach of children unless under aduit supervision. If swallowed, get medical help orcontact a poison control center right away.

Disinfection
Sterilization
No Rinseing

For external use only. Avoid contact with eyesand damaged skin. In case of contact with eyes,rinse thoroughly. lf a rash develops, discontinue use and consult a doctor. Keep away from flames.

label

ALCOHOL DISINFECTANT WIPES 
alcohol disinfectant wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41546-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL230 mL  in 80 
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 80 
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.5 g  in 80 
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.5 g  in 80 
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.5 g  in 80 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41546-017-0180 in 1 BAG; Type 0: Not a Combination Product11/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/26/2020
Labeler - Zhejiang Huanghua Biological Technology Co., Ltd (415467459)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Huanghua Biological Technology Co., Ltd415467459manufacture(41546-017)

Revised: 12/2020
Document Id: b5dbcf01-155c-6397-e053-2995a90a7e36
Set id: b5dbcf01-155b-6397-e053-2995a90a7e36
Version: 1
Effective Time: 20201207
 
Zhejiang Huanghua Biological Technology Co., Ltd