Magicshine Antibacterial Foaming Hand (Benzalkonium Chloride) Liquid [Morgan Gallacher Inc. Dba Custom Chemical Formulators Inc.] -

MAGICSHINE ANTIBACTERIAL FOAMING HAND (BENZALKONIUM CHLORIDE) LIQUID [MORGAN GALLACHER INC. DBA CUSTOM CHEMICAL FORMULATORS INC.]
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NDC	50241-989-01, 50241-989-02
Set ID	262cbce3-9ef7-44a8-b85a-c6ffaa88a4de
Category	HUMAN OTC DRUG LABEL
Packager	Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%
Purpose

Antiseptic
Uses

For hand washing to decrease bacteria on the skin.
Warnings

For external use only.
When Using this Product

- Avoid contact with the eyes.

- In case of eye contact, flush eyes with water. Do not ingest.

- Stop use and contact a doctor if irritation or redness develops

or if condition persist.
Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center immediately.
Directions

-Apply to wet hands, work into a lather and rinse thoroughly.

-Children under 6 years of age should be supervised when using this product.
Inactive Ingredients

Water, Cocamidopropyl Betaine, Caprylyl Glucoside, Glycerine, Tetrasodium EDTA, Fragrance, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol, Yellow #5, Red #40
MAGICSHINE ANTIBACTERIAL FOAMING HAND SOAP

MAGICSHINE ANTIBACTERIAL FOAMING HAND SOAP

INGREDIENTS AND APPEARANCE

MAGICSHINE ANTIBACTERIAL FOAMING HAND
benzalkonium chloride liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 kg in 100 kg

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50241-989-02	1 in 1 BOX	09/18/2018
1	NDC:50241-989-01	3.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/18/2018

Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)

Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)

Name	Address	ID/FEI	Business Operations
Establishment
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture(50241-989) , api manufacture(50241-989) , pack(50241-989)

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