Raspberry Apple Hand Sanitizer (Benzalkonium Chloride) Gel [Shenzhen Lantern Science Co., Ltd.] -

RASPBERRY APPLE HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [SHENZHEN LANTERN SCIENCE CO., LTD.]
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NDC	54860-088-01
Set ID	64021d05-559a-1b5f-e053-2991aa0abefc
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

Antibacterial
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
WARNINGS
Warnings
- for external use only
- if irritation occurs discontinue use
- keep out of eyes
- avoid contact with broken skin
- do not inhale or ingest
- stop use and ask if doctor if skin irritation develops
- keep out of reach of children
- 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, hydroxyethylcellulose, phenoxyethanol, fragrance/parfum, benzalkonium chloride, disodium edta

May Contain

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

To decrease bacteria on hands
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RASPBERRY APPLE HAND SANITIZER
benzalkonium chloride gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54860-088-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/30/2018

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

Name	Address	ID/FEI	Business Operations
Establishment
Shenzhen Lantern Science Co., Ltd.		421222423	manufacture(54860-088)

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Medic