ESTEE LAUDER HAND SANITIZER- alcohol gel

ESTEE LAUDER HAND SANITIZER by

Drug Labeling and Warnings

ESTEE LAUDER HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., NORTHTEC INC, NORTHTEC PALC, Len-Ron Manufacturing Division of Aramis Inc., PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only

Flammable. Keep away from fire or flame.

Do not use

• on children under 2 months
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub together until dry.
• Supervise children under 6 years when using this product to avoid swallowing

Other information

• Store between 59-86F
• Avoid freezing and excessive heat above 104F

Inactive ingredients

water\aqua\eau acrylates/c10-30 alkyl acrylate crosspolymer aminomethyl propanol methyl gluceth-20 t-butyl alcohol <iln48831>

PRINCIPAL DISPLAY PANEL - 8.5 FL. OZ. Bottle Label

ESTĒE LAUDER

Hand Sanitizer

Ethyl Alcohol 70%
Antiseptic Hand Sanitizer

Non-sterile Solution

8.5 FL. OZ.

INGREDIENTS AND APPEARANCE

ESTEE LAUDER HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-059
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
aminomethylpropanol (UNII: LU49E6626Q)
methyl gluceth-20 (UNII: J3QD0LD11P)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-059-01	1 in 1 CARTON	03/25/2020
1		250 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	03/25/2020

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-059) , REPACK(11559-059)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-059)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-059)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-059)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-059)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-059) , REPACK(11559-059)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-059) , REPACK(11559-059)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-059)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-059)