JUSTICE MIXED BERRY SCENT ANTIBACTERIAL 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.

----------

Justice Mixed Berry Scent 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.

Supervise children in the use of this product.

Other Information

Store beow 105 0F (40.5 0C)
May discolor some fabrics.

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.

Inactive Ingredient

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

Product Label

MixedBerryFlower

MixedBerryInside

MixedBerryOutside

JUSTICE MIXED BERRY SCENT ANTIBACTERIAL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60637-031
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)
TROLAMINE (UNII: 9O3K93S3TK)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60637-031-30	1 in 1 CARTON	06/24/2016	10/10/2017
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/18/2015	10/10/2017

Labeler - Tween Brands Inc (965758188)

Revised: 11/2022

Document Id: ed2e5ecd-8a00-7f38-e053-2a95a90a9d97

Set id: 6679db06-a3af-4961-ba7c-23024fd3acc7

Version: 6

Effective Time: 20221111

Tween Brands Inc