ANTI-BACTER HAND SANITIZER 70 ETHYL ALCOHOL PINEAPPLE- 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 Pineapple

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

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

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

place enough gel in your palms to thoroughly cover hand, rub hands together brikly 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:

ALCOHOL DENAT., AQUA, 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, AMINOMETHYL PROPANOL, BENZOPHENONE-3, POTASSIUM SORBATE, SODIUM BENZOATE, LIMONENE, CITRAL, CI 74260, CI 77492, CI 19140, CI 17200
*The letter next to the batch number means:
A-acrylates/C10-30 alkyl acrylate crosspolymer B-carbomer

Package Labeling:

Label6

ANTI-BACTER HAND SANITIZER 70 ETHYL ALCOHOL PINEAPPLE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80457-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80457-007-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/01/2021

Labeler - ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI (366050458)

Revised: 2/2021

Document Id: bc2c1534-476b-7470-e053-2a95a90aacd6

Set id: bc2c1534-476a-7470-e053-2a95a90aacd6

Version: 1

Effective Time: 20210225

ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI