PROBLEND ANTIBACTERIAL CLEANSER- 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.

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PROBLEND ANTIBACTERIAL LIQUID CLEANSER

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 eyes. In case of eye contact,, flush eyes with water.

Do not ingest. Stop use and contact a doctor if irritation or

redness develop or conditions persist for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help

or contact Poison Control Center right away.

Directions

- Pump into hands, wet as needed.

- Lather vigorously for at least 15 seconds. Wash skin, rinse thogoughly and dry.

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

INERT INGREDIENTS:

Water, Cocamidopropyl Betaine, PEG 150 Distearate, Caprylyl Glucoside, Glycerine, Cocamide MIPA, Tetrasodium EDTA, Fragrance, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol, FD&C Blue #1

PROBLEND ANTIBACTERIAL LIQUID CLEANSER

PROBLEND ANTIBACTERIAL LIQUID CLEANSER image description

PROBLEND ANTIBACTERIAL CLEANSER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50241-983
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)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
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:50241-983-02	1 in 1 BOX	09/18/2018
1	NDC:50241-983-01	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	01/24/2022

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(50241-983) , api manufacture(50241-983) , pack(50241-983)

Revised: 1/2022

Document Id: 43307448-c4b6-427f-8833-b1fcd612d2a5

Set id: 37b0fa00-76c5-4130-b38a-aceab2be7283

Version: 5

Effective Time: 20220124

Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.