ANTI-BACTER HAND SANITIZER 70 ETHYL ALCOHOL MELON- 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 70% Ethyl Alcohol Melon

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

Warnings:

For external use only: hands

do not use

  • on broken, cut or irritated skin

When using this product

Keep out of reach of children.

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

stop using and ak a doctor 

if irritation or redness develops or lasts

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

Directions

Other information

Inactive Ingredients:

AQUA (WATER), GLYCERIN, ALOE BARBADENSIS LEAF JUICE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER / CARBOMER*, MANNITOL, MICROCRYSTALLINE CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ALOE BARBADENSIS LEAF JUICE POWDER, TOCOPHERYL ACETATE, ALGIN, PARFUM (FRAGRANCE), AMINOMETHYL PROPANOL, BENZOPHENONE-3, POTASSIUM SORBATE, SODIUM BENZOATE, CI 74260, CI 77492 (IRON OXIDES), CI 19140 (FD&C YELLOW 5), CI 42090 (BLUE 1).
*The letter next to the batch number means:
A-ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER B-CARBOMER

Package Labeling:

Box

ANTI-BACTER HAND SANITIZER 70 ETHYL ALCOHOL MELON 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80457-005
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
OXYBENZONE (UNII: 95OOS7VE0Y)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80457-005-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/01/2021
Labeler - ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI (366050458)

Revised: 3/2021
Document Id: bd08213a-bfc1-3c1d-e053-2a95a90adbc7
Set id: bc2c2d73-be23-f28a-e053-2a95a90af99d
Version: 2
Effective Time: 20210308
 
ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI