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NDC 44119-0011-02 Disney Frozen II Antibacterial Hand Wipes 1.3 mg/mL Details

Disney Frozen II Antibacterial Hand Wipes 1.3 mg/mL

Disney Frozen II Antibacterial Hand Wipes is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Peachtree Playthings, Inc.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	44119-0011
Product ID	44119-011_b696cfca-5027-21e8-e053-2a95a90ad520
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Disney Frozen II Antibacterial Hand Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Peachtree Playthings, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 44119-0011-02 (44119001102)

Pricing Information	N/A
NDC Package Code	44119-011-02
Billing NDC	44119001102
Package	80 PATCH in 1 POUCH (44119-011-02) / 3.15 mL in 1 PATCH
Marketing Start Date	2021-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b696fb9b-2941-492d-e053-2995a90a5e17 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/01/2021

Labeler - Peachtree Playthings, Inc. (053882515)

Revised: 12/2020

Document Id: b696cfca-5027-21e8-e053-2a95a90ad520

Set id: b696fb9b-2941-492d-e053-2995a90a5e17

Version: 1

Effective Time: 20201216