HAND SANITIZER- alcohol gel 
WESSCO International

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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WESSCO International
Hand Sanitizer 5000ml

Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce germs on the skin.

Warnings

Do not use

When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if irritation or redness develops and lasts.

Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

Other information

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Aloe Barbadensis leaf Juice, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water.

Package Label - Principal Display Panel

5000mL NDC: 42509-021-01 5000ml label5000ml label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42509-021
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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42509-021-015000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/22/2020
Labeler - WESSCO International (118553619)
Establishment
NameAddressID/FEIBusiness Operations
WESSCO International118553619label(42509-021)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang iColor Biotech Co., Ltd554528308manufacture(42509-021)

Revised: 7/2020
Document Id: ab0a4495-0659-6f2a-e053-2a95a90a9962
Set id: ab0a4495-065a-6f2a-e053-2a95a90a9962
Version: 1
Effective Time: 20200722
 
WESSCO International