Frozen Grape Hand Sanitizer (Benzalkonium Chloride) Gel [Shenzhen Lantern Science Co. Ltd.] -

FROZEN GRAPE HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [SHENZHEN LANTERN SCIENCE CO. LTD.]
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NDC	54860-034-01
Set ID	35313193-6f0e-1ac2-e054-00144ff88e88
Category	HUMAN OTC DRUG LABEL
Packager	shenzhen Lantern Science Co. Ltd.
Generic Name
Product Class
Product Number
Application Number	PART333E

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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.
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).
INDICATIONS & USAGE

Frozen Grape Hand Sanitizer

2 FL OZ (59mL)
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FROZEN GRAPE HAND SANITIZER
benzalkonium chloride gel

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

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54860-034-01	59 g in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/13/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
shenzhen Lantern Science Co. Ltd.		421222423	manufacture(54860-034)

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