DISNEYTSUM TSUM BUBBLE GUM (PINK) HAND SANITIZER DISNEYTSUM TSUM- benzalkonium chloride gel

DisneyTsum Tsum Bubble Gum (pink) Hand Sanitizer by

Drug Labeling and Warnings

DisneyTsum Tsum Bubble Gum (pink) Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Townley, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose: Antibacterial

PURPOSE

Use

To decrease bacteria on the skin that could cause disease.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Hand Sanitizer

2 FL OZ (59mL)

WARNINGS

Warnings

• for external use only-hands.
• keep out of eyes. avoid contact with broken skin.
• stop use and ask a Doctor if irritation or redness develops.
• do not inhale or ingest. if swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions

• Rub a dime sized drop into hands.
• For children under 6 use under adult supervision.

INACTIVE INGREDIENT

Inactive Ingredients

water (aqua/eau), glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, triethanolamine, PEG-40 hydrogenated castor oil, fragrance (parfum).

May Contain

Red 40 (CI 16035), Red 33 (CI 17200), Blue 1 (CI 42090), Yellow 5 (CI 19140).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DISNEYTSUM TSUM BUBBLE GUM (PINK) HAND SANITIZER  DISNEYTSUM TSUM
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58737-165
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 g  in 59 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCETH-7 CARBOXYLIC ACID (UNII: 35KO064932)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
METHOXY PEG-40 (UNII: 6AXS45P1QU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	red (Red 40, Red 33) , yellow (Yellow 5) , blue (Blue 1)	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58737-165-01	59 g in 1 BOTTLE; Type 0: Not a Combination Product	08/23/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/23/2016

Labeler - Townley, Inc. (016956158)

Establishment
Name	Address	ID/FEI	Business Operations
Townley, Inc.		016956158	manufacture(58737-165)