FROZEN BUBBLE GUM HAND SANITIZER- benzalkonium chloride gel

Frozen Bubble Gum Hand Sanitizer by

Drug Labeling and Warnings

Frozen Bubble Gum Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by shenzhen Lantern Science Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.01%



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

Frozen Bubble Gum 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), coceth-7, PPG-1-PEG-9 lauryl glycol ether, triethanolamine, PEG-40 hydrogenated castor oil, chloropropylate, fragrance (parfum).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FROZEN BUBBLE GUM HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54860-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.01 g  in 59 g

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCETH-7 CARBOXYLIC ACID (UNII: 35KO064932)
CHLOROPROPYLATE (UNII: GI03ROM7HQ)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54860-033-01	59 g in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/08/2016

Labeler - shenzhen Lantern Science Co. Ltd. (421222423)

Establishment
Name	Address	ID/FEI	Business Operations
shenzhen Lantern Science Co. Ltd.		421222423	manufacture(54860-033)