PROBLEND ANTIBACTERIAL FOAM- benzalkonium chloride liquid
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

PROBLEND ANTIBACTERIAL FOAM

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. right away.

Directions

-pump into hands, wet as needed.

-Lather vigorously for at least 15 seconds.

-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

image description

PROBLEND ANTIBACTERIAL FOAM
benzalkonium chloride liquid

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

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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50241-988-02	1 in 1 BOX	09/20/2018	12/29/2022
1	NDC:50241-988-01	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		09/20/2018	12/29/2022

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(50241-988) , api manufacture(50241-988) , pack(50241-988)

Revised: 12/2022

Document Id: ba9922cf-cb29-4d88-8625-7350f182ff11

Set id: da84e22c-4d76-43a4-ad0d-61aa2f681d2a

Version: 5

Effective Time: 20221229

Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.