YANKEE CANDLE HAND SANITIZER WITH MOISTURIZER PINK SANDS- alcohol gel

YANKEE CANDLE HAND SANITIZER with moisturizer by

Drug Labeling and Warnings

YANKEE CANDLE HAND SANITIZER with moisturizer by is a Otc medication manufactured, distributed, or labeled by THE YANKEE CANDLE COMPANY INC, Tri-Pac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Ethyl Alcohol 62.5%

Purpose

Antiseptic Cleanser

Use

To help reduce bacteria on hands.

Warnings

For external use only.

Flammable, keep away from fire, flame or sparks.

Do not use on damaged or broken skin | in or near eyes, ears or mouth | on children less than 2 months of age.

When using this product if in the eyes rinse thoroughly with water | discontinue use if irritation and/or redness develops.

Stop use and ask doctor if irritation or rash appears on the skin and persists for 72 hours.

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

Directions

• Apply product onto hands, spread thoroughly and rub dry.
• Children under 6 years of age should be supervised by an adult to avoid swallowing.

Other information

• Store between 59-86F (15-30C)
• Avoid freezing and excessive heat above 104F (40C)
• May discolor certain fabrics or surfaces
• Harmful to wood finishes and plastics

Inactive ingredients

Aqua (Water), Propylene Glycol, Dimethicone PEG-7 Isostearate, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Denatonium Benzoate, Tert Butyl Alcohol, 2-Amino-2-Methyl-1-Propanol, 2-Methylamino-2-Methyl-1-Propoanol, Tocopherol Acetate (Vitamin E), fragrance.

Questions?

Call 877-803-6890

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY YANKEE CANDLE, INC.
16 YANKEE CANDLE WAY, SOUTH DEERFIELD, MA 01373 USA

PRINCIPAL DISPLAY PANEL - 118.3 ML Bottle Label

YANKee
CANDLe®

GEL HAND
SANITIZER
with moisturizer

PINK
SANDS™
with essential oils

KILLS 99.99% OF MOST GERMS*

62.5% ALCOHOL

NET WT 4 FL OZ (118.3 ML)

INGREDIENTS AND APPEARANCE

YANKEE CANDLE HAND SANITIZER WITH MOISTURIZER   PINK SANDS
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80123-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	62.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE PEG-7 ISOSTEARATE (UNII: JVS3399FNW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80123-001-01	118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020
2	NDC: 80123-001-02	3 in 1 PACKAGE	10/26/2020
2		118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 80123-001-03	236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020
4	NDC: 80123-001-04	2 in 1 PACKAGE	10/26/2020
4		236.6 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	10/26/2020

Labeler - THE YANKEE CANDLE COMPANY INC (066983586)

Establishment
Name	Address	ID/FEI	Business Operations
Tri-Pac, Inc.		020844956	MANUFACTURE(80123-001)