Grape Scented Hand Sanitizer (Benzalkonium Chloride) Gel [Foshan Jinxiong Technology Co., Ltd] -

GRAPE SCENTED HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [FOSHAN JINXIONG TECHNOLOGY CO., LTD]
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NDC	69795-014-01
Set ID	331224cd-4473-4a82-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Foshan Jinxiong Technology Co., Ltd
Generic Name
Product Class
Product Number
Application Number	PART333A

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Active Ingredient

Benzalkonium Chloride 0.1%
Purpose

Antibacterial
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
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,
Directions
- Rub a dime sized drop into hands.
- For children under 6 use under adult supervision.
Inactive Ingredients

water, glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, sodium hydroxide, PEG-40 hydrogenated castor oil, fragrance
Use

To decrease bacteria on the skin that could cause disease.
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GRAPE 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	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCETH-7 (UNII: 58Y261JLH5)
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69795-014-01	59 g in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/16/2016

Labeler - Foshan Jinxiong Technology Co., Ltd (544328419)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Jinxiong Technology Co., Ltd		544328419	manufacture(69795-014)

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Medic