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

for travel, shopping, school, work and home use
to help reduce bacteria on the skin
for use when water and soap are not available
recommended for repeated uses

Warnings:

For External use only: hands

flammable, keep away from sources of heat or fire
do not use on broken, cut or irritated skin

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

place enough gel in your palms to thoroughly cover your hands, rub hands together briskly until dry
children under 6 years of age should be supervised when using Anti-Bacter Hand Sanitizer
not recommended for infants

Other information

store at a temperature below 104°F (40°C)
may discolor certain fabrics and surfaces

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:

ANTI BACTER HAND SANITIZER MED CLEAN NO WATER NEEDED WITH ALOE VERA AND GLYCERINE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80457-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80457-001-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/11/2020

Labeler - ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI (366050458)

Revised: 3/2021

Document Id: bdc092cd-a8f6-c5b8-e053-2995a90ab1fd

Set id: b2e8a00e-0af1-7b49-e053-2a95a90abddf

Version: 4

Effective Time: 20210317

ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI