DISNEY FROZEN II ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

Disney Frozen II Antibacterial Hand Wipes by

Drug Labeling and Warnings

Disney Frozen II Antibacterial Hand Wipes by is a Otc medication manufactured, distributed, or labeled by Peachtree Playthings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

decreases bacteria on skin

Warnings

For external use only

Do not use

if you are allergic to any ingredients

When using this product

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

Use of the product by children should be supervised by an adult

Stop use and ask a doctor if 

irritation or rash develops and continues for more than 72 hours.

Directions

• adults and children 2 years and over:
  • Apply to hands
  • Allow to dry without wiping
• children under 2 years: ask a doctor before use

Inactive ingredients

Water, Phenoxyethanol, Propylene Glycol, GLycerin, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate.

Package Labeling:20 wipes

Package Labeling:80 wipes

INGREDIENTS AND APPEARANCE

DISNEY FROZEN II ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44119-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44119-011-01	20 in 1 POUCH	04/01/2021
1		3.15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 44119-011-02	80 in 1 POUCH	04/01/2021
2		3.15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2021

Labeler - Peachtree Playthings, Inc. (053882515)