DISNEY FROZEN ANTIBACTERIAL HAND WIPES - benzalkonium chloride liquid 
Peachtree Playthings, 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 FROZEN Antibacterial Hand Wipes

Disney FROZEN Antibacterial Hand Wipes


Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Use

decreases bacteria on skin

Warnings

For external use only

Do not use if you are allergic to any of the ingredients.

When using this product avoid contact with 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

Inactive Ingredients

Water, Propylene Glycol, Phenoxyethanol, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Glycerin, Ceteareth-12, Cetyl Palmitate, Disodium EDTA, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract,2-Bromo-2-Nitropropane-1,3-Diol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone


Questions?

Call Toll Free 1-800-635-3969

Distributed By:

Peachtree Playthings

P.O.Box 723665, Atlanta, GA 31139

MADE IN CHINA (TIANJIN)

Disney

disney.com/Frozen

2014 Peachtree Playthings

All Rights Reserved

www.peachtreeplaythings.com

Disney FROZEN Antibacterial Hand Wipes 16 Pack (44119-006-16)


Label

DISNEY FROZEN ANTIBACTERIAL HAND WIPES 
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44119-006
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BRONOPOL (UNII: 6PU1E16C9W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:44119-006-16 38 g in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/26/2014
Labeler - Peachtree Playthings, Inc. (053882515)
Establishment
Name Address ID/FEI Business Operations
Concept Products Ltd 421342352 manufacture(44119-006)

Revised: 3/2014
Document Id: 20b3f1e1-d77e-4ede-a261-12d71e0f249f
Set id: 62bf47a8-4180-4f44-ae09-c0239c1c017b
Version: 1
Effective Time: 20140326
 
Peachtree Playthings, Inc.