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.

----------

store between 15-30°C(59-86°F)
avoid freezing and excessive heat above 40°C(104°F)

pure water

open the package lid and wipe skin until dry.

alcohol

Benzalkamine

2-methyl-4-isothiazoline-3-one

propylene glyco

2-phenoxyethanol

For children less than 2 months of age.

On open skin wounds.

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

Disinfection
Sterilization
No Rinseing

Stop use and ask a doctor if irritation or rash occurs.These maybe signs of a serious condition.

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

label

ALCOHOL DISINFECTANT WIPES 
alcohol disinfectant wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41546-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL160 mL  in 50 
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 50 
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.5 g  in 50 
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.5 g  in 50 
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.5 g  in 50 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41546-016-0150 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(41546-016)

Revised: 12/2020
Document Id: b5dbc6ab-acfd-87a0-e053-2a95a90a69c3
Set id: b5dbc6ab-acfc-87a0-e053-2a95a90a69c3
Version: 1
Effective Time: 20201207
 
Zhejiang Huanghua Biological Technology Co., Ltd