HAND SANITIZER WIPES- ethanol cloth 
Polypak Industries AG

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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For Handwashing to decrease bacteria on the skin

Apply sufficient amount to thoroughly wet all surfaces of hands
and fingers. Rub onto hands until dry.
Children under 6 should be supervised when using this product. For Handwashing to decrease bacteria on the skin

Flammable. Keep away from heat or flame.
When using this product
Do not use in or near the eyes. In case of contact, rinse eyes thoroughly
with water.
Keep out of reach of children if swallowed get medical help or contact
a Poison Control Center right away.
Stop use and ask a doctor if irritation or rash occurs and lasts

warnings section

glycerin, water

inactive ingredients

For Handwashing to decrease bacteria on the skin

Indications

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

Keep out of reached of children

Hand sanitizing wipes - for handwashing to decrease bacteria on the skin

Purpose

Alcohol - 75%

Active ingredients

alcoholwipepolypak.jpg

alcoholwipepolypak.jpg 80285-129-01

HAND SANITIZER WIPES 
ethanol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80285-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80285-129-015 in 1 BOX10/21/2020
14 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/21/2020
Labeler - Polypak Industries AG (224679539)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Youquan Care Products Technology Co., Ltd.421318425manufacture(80285-129)

Revised: 10/2020
Document Id: b2d0d207-ec29-fdd1-e053-2a95a90aef5d
Set id: b232c3eb-36a1-27a8-e053-2995a90aa761
Version: 4
Effective Time: 20201029
 
Polypak Industries AG