PREMIUM PROTECTION 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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Premium Protection Antibacterial Hand Soap

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, rinse eyes thoroughly with water.

Do not ingest.

Stop use and contact a doctor if irritation and redness develop

and conditions persist.

Keep out of reach of children.

If swallowed, get medical help

or contact Posion Control Center immediately

Directions

Apply to wet hands. Work into a latther and rinse thoroughly. Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Cocamidopropyl Betaine, PEG 150 Distearate, Caprylyl Glucoside, Glycerine, Cocamide MIPA, Tetrasodium EDTA, Fragrance, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol, Yellow #5, Red #40

Maintex Premium Protection Antibacterial Hand Soap

Premium Protection Antibacterial Hand Soap image description

PREMIUM PROTECTION ANTIBACTERIAL HAND
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50241-016
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50241-016-02	4 in 1 BOX	04/15/2018	07/14/2020
1	NDC:50241-016-01	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		04/15/2018	07/14/2020

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(50241-016) , api manufacture(50241-016) , pack(50241-016)

Revised: 7/2020

Document Id: aa7512d0-1e02-edc8-e053-2a95a90a11c4

Set id: 3f50cb49-c2b7-4855-bf44-aac66785b11d

Version: 3

Effective Time: 20200715

Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.