JUSTICE COTTON CANDY SCENTED ANTI BACTERIAL HAND SANITIZER- alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Tween Brands, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- For hand washing to decrease bacteria on the skin. - Recommended for repeated use.
Authorization status:
OTC monograph not final
Authorization number:
60637-231-00

JUSTICE COTTON CANDY 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 Cotton Candy Scented Anti-bacterial Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 62%

Purpos e

Antiseptic

Us e

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. Expiry Date:06/2023

Inactive ingredients

Water, Glycerin, Propylene Glycol, Fragrance Carbomer, Triethanolamine, Polyethylene Terephthalate,

Acrylates Copolymer, Red 40.

Package Labeling:

JUSTICE COTTON CANDY SCENTED ANTI BACTERIAL HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 6 37-231

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 20 mg in 1 mL

Inactive Ingredients

Tween Brands, Inc.

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID CO PO LYMER ( 18 0 0 0 MW) (UNII:

JZ1374NL9 E)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 6 37-231-0 0

30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/19 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 4/19 /20 19

Labeler -

T ween Brands, Inc. (965758188)

Revised: 11/2019

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