ADVANCED HAND SANITIZER- alcohol gel 
UNISOURCES GROUP 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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Advanced Hand Sanitizer

Drug Facts

Active ingredient

Ethyl alcohol 72%

Purpose

Antiseptic

Uses

Warnings

Do not use 

  • in or near the eyes. in case of contact, flush eyes with water.

Stop use and ask a doctor if

  • irritation or rash appears and lasts.

Keep out of reach of children.

  • If need, get medical help or contact a Poison Control Center.

Directions

Other information

Inactive ingredients

Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine.

Package Labeling: 59mL

Bottle

Package Labeling: 236mL

Label2

Package Labeling: 295mL

Bottle3

ADVANCED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75311-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.72 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75311-000-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
2NDC:75311-000-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
3NDC:75311-000-03295 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/31/2020
Labeler - UNISOURCES GROUP LLC (117474227)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Huiji Biotechnology Co., Ltd.526893497manufacture(75311-000)

Revised: 6/2020
Document Id: a8d55d54-9284-49d9-e053-2995a90a201f
Set id: c76782a1-6868-4295-a9d2-f79c562b51be
Version: 2
Effective Time: 20200624
 
UNISOURCES GROUP LLC