DISNEY MINNIE ANTISEPTIC HAND CLEANSING COTTON CANDY SCENTED- alcohol gel
Bolero Home Decor, 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.

----------

Disney Minnie Antiseptic Hand Cleansing Gel Cotton Candy Scented

Active Ingredient

Alcohol 62% v/v

Purpose

Antiseptic

Use

Decreases bacteria on hands

Warnings

For external use only

Flammable, keep away from fire or flame

When using this product

do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

if irritation or rash develops and continues 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

Place a 'palmful' of product in one hand. Spread on both hands and rub the skin until dry.

Inactive Ingredients

water, carbomer, triethanolamine, fragrance, propylene glycol, glycerin, tocopheryl acetate, aloe barbadensis leaf juice, fragrance, red 4 (CI 14700), red 33 (CI 17200).

Disney Minnie Antiseptic Hand Cleansing Gel

Distributed by:
Bolero Home Decor, Inc.
Sherman Oaks, Ca 91413
www.BoleroHD.com

MADE IN CHINA

For additional Information
or Comments, please call
(888) 831-7029

Disney Minnie Antiseptic Hand Cleansing Gel Cotton Candy Scented 1oz/30ml (57469-011-00)

Minnie Hand Gel

DISNEY MINNIE ANTISEPTIC HAND CLEANSING COTTON CANDY SCENTED
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57469-011
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)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57469-011-00	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/13/2013	01/20/2015

Labeler - Bolero Home Decor, Inc. (009777118)

Revised: 7/2016

Document Id: 3693a16e-43e0-6a54-e054-00144ff88e88

Set id: 515b64b8-7d54-4697-a2aa-5af4511189ea

Version: 5

Effective Time: 20160701

Bolero Home Decor, Inc.