JUSTICE COOL CANDY PINK SCENTED ANTI-BACTERIAL HAND SANITIZER- alcohol gel
Tween Brands, Inc

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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Justice Cool Candy Pink Scented Anti-Bacterial Hand Sanitizer

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, FD&C Red No.40, D&C Red No.33.

Package Labeling:

Outer Package c Inner Package

JUSTICE COOL CANDY PINK SCENTED ANTI-BACTERIAL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60637-074
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
MICA (UNII: V8A1AW0880)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60637-074-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/27/2016

Labeler - Tween Brands, Inc (965758188)