Fruit Fight Scented Hand Sanitizer (Benzalkonium Chloride) Gel [Shenzhen Lantern Science Co., Ltd.] -

FRUIT FIGHT SCENTED HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [SHENZHEN LANTERN SCIENCE CO., LTD.]
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NDC	54860-079-01, 54860-079-02
Set ID	464c6c05-5061-24ea-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 0.1%

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.
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, hydrogenated castor oil, fragrance (parfum).

May Contain

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

Hand Sanitizer
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRUIT FIGHT SCENTED HAND SANITIZER
benzalkonium chloride gel

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCETH-7 CARBOXYLIC ACID (UNII: 35KO064932)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54860-079-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2017	01/19/2017
2	NDC:54860-079-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/17/2017

Labeler - Shenzhen Lantern Science Co., Ltd. (421222423)

Name	Address	ID/FEI	Business Operations
Establishment
Shenzhen Lantern Science Co., Ltd.		421222423	manufacture(54860-079)

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