Antimicrobial Lotion Hand Soap

Antimicrobial Hand by

Drug Labeling and Warnings

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

Drug Details [pdf]

ANTIMICROBIAL 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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Antimicrobial Lotion 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 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 a lather and rinse thoroughly.

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, Yellow #5, Red #40

Antimicrobial Lotion Hand Soap

Antimicrobial Lotion Hand Soap

ANTIMICROBIAL HAND 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77617-008
Route of Administration	TOPICAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77617-008-02	1 in 1 BOX	04/15/2018
1	NDC: 77617-008-01	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	11/18/2022

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Maintex		008317307	manufacture(77617-008) , api manufacture(77617-008) , pack(77617-008)

Revised: 1/2022

Document Id: 47a13236-aee7-49d9-9b93-d98126f3bf1b

34390-5

Set id: a1ca125f-6586-4ed5-8515-05e27b68d341

Version: 5

Effective Time: 20220118