HAND SANITIZER- hand sanitizer gel 
Guangzhou BEAVER Cosmetic 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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HAND SANITIZER

Active Ingredient

Ethyl Alcohol 75%V/V

Purpose

Antisepic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.

Warnings

For external use only.Flammable.Keep away from

heat or flame.

Do not use

in children less than 2 months of age

on open skin wounds

When using this product

keep out of eyes, ears,and mouth.In case of contact with eyes, rinse eyes thoroughly with water.


Stop use and ask a doctor

if irritation or rash occurs.These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Conrol Center right away.

Directions

Place enough product on hands to cover all surfaces.Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C(59-86F)

Avoid freezing and excessive heat above 40C(104F)

Inactive ingredients

Glycerin, Carbomer 940,Dichlorobenzyl Alcohol,Tromethamine, Grape,Aloe Andongensis Leaf,Calendula Officinalis Flower, Phenoxyethanol,Ethylhexylglycerin, Water.

Package Label - Principal Display Panel

75 ml label 100 ml label 250 ml label 500 ml label 1000 ml label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74159-002
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ)  
GRAPE (UNII: 6X543N684K)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74159-002-0175 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
2NDC:74159-002-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
3NDC:74159-002-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
4NDC:74159-002-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
5NDC:74159-002-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2020
Labeler - Guangzhou BEAVER Cosmetic Co.,Ltd. (420020595)
Registrant - Guangzhou BEAVER Cosmetic Co.,Ltd. (420020595)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou BEAVER Cosmetic Co.,Ltd.420020595manufacture(74159-002)

Revised: 5/2020
Document Id: a610c4b6-e48b-554d-e053-2a95a90a7ace
Set id: a6120ea5-017a-8747-e053-2995a90a6953
Version: 1
Effective Time: 20200520
 
Guangzhou BEAVER Cosmetic Co.,Ltd.