DISNEY PLANES FIRE AND RESCUE BERRY SCENTED ANTISEPTIC HAND CLEANSING- 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.

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Disney PLANES FIRE & RESCUE BERRY SCENTED Antiseptic Hand CLEANSING GEL

Disney PLANES FIRE & RESCUE BERRY SCENTED Antiseptic Hand CLEANSING GEL


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, blue 1 (CI 42090), red 33 (CI 17200).

Disney PLANES FIRE & RESCUE BERRY SCENTED Antiseptic Hand CLEANSING GEL 2oz/59ml (57469-055-59)

Disney Planes Gel

DISNEY PLANES FIRE AND RESCUE BERRY SCENTED ANTISEPTIC HAND CLEANSING 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57469-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57469-055-591 in 1 CARTON06/29/2016
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/08/201401/20/2015
Labeler - Bolero Home Decor, Inc. (009777118)

Revised: 7/2016
Document Id: 3693a16e-4426-6a54-e054-00144ff88e88
Set id: 3077b0fa-d0ed-478f-b5f9-7e531401c1a8
Version: 5
Effective Time: 20160701
 
Bolero Home Decor, Inc.