JUSTICE BERRY SCENTED ANTI-BACTERIAL HAND SANITIZER- alcohol gel

Justice Berry Scented Anti-bacterial Hand Sanitizer by

Drug Labeling and Warnings

Justice Berry Scented Anti-bacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Tween Brands, Inc., Bath Concept Cosmetics (Dongguan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 62%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Recommended for repeated use

Directions

Wet hands thoroughly with product and allow to dry without wiping

Warnings

Flammable, keep away from fire or flame

For external use only. Do not use in the eyes the eyes or apply the eyes or apply over large areas of the body

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor

Use only directed. Do not drink. If taken internally, it will produce serious gastric disturbance

Stop use and ask a doctor if irritation persists for more than 72 hours

Keep out of reach of children

If swallowed gel medical helpo r contact a Poison Control Center right away

Supervise children in the use of this product

Inactive ingredients

Water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, polyethylene terephthalate, acrylates copolymer, FD&C red No. 40, D&C Red No. 33

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JUSTICE BERRY SCENTED ANTI-BACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60637-219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
2,4-D-TROLAMINE (UNII: E6SLK39VZN)
POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.40-0.70) (UNII: Y78AJD3DED)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60637-219-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/20/2018

Labeler - Tween Brands, Inc. (965758188)

Establishment
Name	Address	ID/FEI	Business Operations
Bath Concept Cosmetics (Dongguan) Co., Ltd		529623933	manufacture(60637-219)