ANTI BACTER HAND SANITIZER MED CLEAN NO WATER NEEDED WITH ALOE VERA AND GLYCERINE- alcohol gel 
ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI

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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Anti-Bacter Hand Sanitizer Med-Clean, 70% Ethyl Alcohol No Water Needed with Aloe Vera and Glycerine

Drug Facts

Active Ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

Warnings:

For External use only: hands

When using this product

  • avoid contact with eyes, if contact occurs, rinse thoroughly with water, 

stop using and ak a doctor

if irritation or redness develops or lasts 

keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center immediately

Directions

Other information

Inactive ingredients:

Water, Glycerin, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl acrylate crosspolymer/carbomer*, mannitol, microcrystaline cellylose, hydroxypropyl methylcallulose, aloe barbadensis leaf juice powder, tocopheryl acecate, algin, parfum (fragrance), aminomethyl propanol, benzophenone-3, potassium sorbate, sodium benzoate, CI 74260, CI 77492 ( Iron Oxide), CI 19140 (FD&C Yellow 5), CI 42090 (Blue 1).

*The letter next to the batch number means:

A- acrylates/C1O-3O alkyl acrylate crosspolymer B-carbomer

Package Labeling:

002

ANTI BACTER HAND SANITIZER MED CLEAN NO WATER NEEDED WITH ALOE VERA AND GLYCERINE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80457-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80457-001-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/11/2020
Labeler - ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI (366050458)

Revised: 3/2021
Document Id: be607a15-4e43-f635-e053-2995a90a8eb0
Set id: b2e8a00e-0af1-7b49-e053-2a95a90abddf
Version: 5
Effective Time: 20210325
 
ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI