Cole Antimicrobial Premium Hand Soap

Cole Antimicrobial Premium Hand by

Drug Labeling and Warnings

Cole Antimicrobial Premium Hand by is a Otc medication manufactured, distributed, or labeled by Maintex. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLE ANTIMICROBIAL PREMIUM HAND- benzalkonium chloride liquid 
Maintex

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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Cole Antimicrobial Premium 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.

If contact occurs, 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 Poison Control Center immediately.

Directions

-Apply to wet hands.

-Work into lather 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

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

Cole Antimicrobial Premium Hand Soap

Cole Antimicrobial Premium Hand Soap

COLE ANTIMICROBIAL PREMIUM HAND 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77617-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77617-006-02	1 in 1 BOX	04/15/2018
1	NDC: 77617-006-01	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		04/15/2018	11/04/2023

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc.		008317307	manufacture(77617-006) , api manufacture(77617-006) , pack(77617-006)

Revised: 1/2022

Document Id: 2d9e678b-c700-481f-ac25-bd4be8c4c1db

34390-5

Set id: 3de4f69a-5976-44ec-ac49-5d4d0c37cc44

Version: 4

Effective Time: 20220117