PROBLEND ANTIBACTERIAL FOAM- benzalkonium chloride liquid

PROBLEND ANTIBACTERIAL FOAM by

Drug Labeling and Warnings

PROBLEND ANTIBACTERIAL FOAM by is a Otc medication manufactured, distributed, or labeled by Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 for more than 72 hours. 

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

-pump into hands, wet as needed.

-Lather vigorously for at least 15 seconds.  W

-Wash skin, rinse thoroughly and dry.

Inactive Ingredients

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

Problend Antibacterial Foam

Problend Antibacterial Foam

INGREDIENTS AND APPEARANCE

PROBLEND ANTIBACTERIAL FOAM 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50241-988
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50241-988-02	1 in 1 BOX	09/20/2018
1	NDC: 50241-988-01	3.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/20/2018

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture(50241-988) , api manufacture(50241-988) , pack(50241-988)