ALCOHOL WIPES- alcohol 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 between 15-30°C(59-86°F),avoid freezing and excessive heat above 40°C(104°F)

pure water

1.Open cover and remove seal.
2.Pull out wipe corner from center of the roll.
3.Thread through hole in the cover.
4.Close lid after use to retain moisture.

alcohol

Benzalkamine

2-methyl-4-isothiazoline-3-one

propylene glyco

2-phenoxyethanol

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

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

Disinfection
Sterilization
No Rinseing

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

label

ALCOHOL WIPES 
alcohol wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41546-009
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL346 mL  in 80 
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.6 g  in 80 
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.6 g  in 80 
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.6 g  in 80 
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.6 g  in 80 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41546-009-0180 in 1 PAIL; Type 0: Not a Combination Product09/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/10/2020
Labeler - Zhejiang Huanghua Biological Technology Co., Ltd (415467459)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Huanghua Biological Technology Co., Ltd415467459manufacture(41546-009)

Revised: 10/2020
Document Id: b2db2f61-2ecb-a5bf-e053-2a95a90a00e8
Set id: aeed7e1d-7ad8-7eff-e053-2995a90a1ca8
Version: 2
Effective Time: 20201029
 
Zhejiang Huanghua Biological Technology Co., Ltd