HY-G-CLENZ ANTIBACTERIAL HAND- 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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Hy-G-Clenz Antibacterial Hand Soap

ACTIVE INGREDIENT

Benzalkonium Chloride..........0.13%

Purpose

Antimicrobial

Uses

Hand Wash

Warnings

For external use only.

When Using this Product

Do not use in or near eyes.

Keep out of reach of children.

In case of accidental ingestion, seek medical attention or contact a

Poison Control Center immediately.

Directions

- Apply small amount of product to hands.

- Hold hands under water and work cleaner into lather.

- Rinse hands with water and wipe clean.

INERT INGREDIENTS:

Water, Cocamidopropyl Betaine, PEG 150 Distearate, Caprylyl Glucoside, Glycerine, Cocamide MIPA, Tetrasodium EDTA, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol.

Hy-G-Clenz Antibacterial Hand Soap

image description

HY-G-CLENZ ANTIBACTERIAL HAND
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50241-984
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:50241-984-02	1 in 1 BOX	09/25/2018
1	NDC:50241-984-01	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		09/25/2018	12/19/2022

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(50241-984) , api manufacture(50241-984) , pack(50241-984)

Revised: 12/2022

Document Id: a85dd86c-8133-4b36-a38a-00912a5c2622

Set id: 5626ac95-6099-4170-b561-691249c1b0dc

Version: 6

Effective Time: 20221219

Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.