BACTIVE HAND SANITIZER- ethyl alcohol gel 
Zuru LLC

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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Active Ingredient(s)

Ethyl Alcohol 70%.

Purpose

Antiseptic

Use

Warnings

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

When using this product

■ keep out of eyes. In case of contact with eyes, flush thoroughly with water.

■ avoid contact with broken skin.

■ do not inhale or ingest.

Stop use and ask a doctor

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

Directions

Other information

Inactive ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbedensis leaf extract, aminomethyl propanol, fragrance, glycerin, maltodextrin, water

Package Label - Principal Display Panel

50 mL 50 mL label

500 mL 500 mL label

2L 2L label

BACTIVE HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76658-115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76658-115-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
2NDC:76658-115-092000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/17/2020
3NDC:76658-115-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/17/2020
Labeler - Zuru LLC (080435986)
Establishment
NameAddressID/FEIBusiness Operations
Opal Cosmetics (Huizhou) Limited528178475manufacture(76658-115) , label(76658-115)

Revised: 6/2020
Document Id: a474cb7b-8818-f109-e053-2995a90abcd5
Set id: a56bec5a-d34c-2568-e053-2995a90a5ffb
Version: 1
Effective Time: 20200616
 
Zuru LLC