JUSTICE FROSTED VANILLA SCENTED ANTI-BACTERIAL HAND SANITIZER- alcohol gel

Justice Frosted Vanilla Scented Anti-Bacterial Hand Sanitizer by

Drug Labeling and Warnings

Justice Frosted Vanilla Scented Anti-Bacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Tween Brands, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 62%

Purpose

Antiseptic

Use

• For hand washing to decrease bacteria on the skin.
• Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame.

For external use only.

Do not use

in 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 as directed. Do not drink. If taken internally, it will produce serious gastric disturbances.

Stop use and ask a doctor if

Irritation persists for more than 72 hours.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

• Wet hands thoroughly with product and allow to dry without wiping.
• Supervise children in the use of this product.

Other information

• Store below 105°F (40.5°C).
• May discolor some fabrics.

Inactive ingredients

Water, Glycerin, Propylene Glycol, Fragrance, Carbomer, Triethanolamine, Mica, D&C Red No. 33 , FD&C Blue No. 1 .

Package Labeling:

INGREDIENTS AND APPEARANCE

JUSTICE FROSTED VANILLA SCENTED ANTI-BACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60637-091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
MICA (UNII: V8A1AW0880)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60637-091-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/25/2016

Labeler - Tween Brands, Inc (965758188)