FRESH HANDS FOAMING ANTIBACTERIAL HAND SOAP

FRESH HANDS FOAMING ANTIBACTERIAL HAND by

Drug Labeling and Warnings

FRESH HANDS FOAMING ANTIBACTERIAL HAND by is a Otc medication manufactured, distributed, or labeled by Maintex. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRESH HANDS FOAMING ANTIBACTERIAL 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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FRESH HANDS FOAMING 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, flush eyes with water. Do not ingest.

Stop use and contact a doctor if irritation or redness develops

or if condition persist.

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help

or contact a 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.

Inactive Ingredients

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

BUTLER FRESH HANDS FOAMING ANTIBACTERIAL HAND SOAP

BUTLER FRESH HANDS FOAMING ANTIBACTERIAL HAND SOAP

FRESH HANDS FOAMING ANTIBACTERIAL HAND 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77617-011
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)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77617-011-02	1 in 1 BOX	09/16/2018
1	NDC: 77617-011-01	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		09/16/2018	01/24/2022

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Maintex		008317307	manufacture(77617-011) , api manufacture(77617-011) , pack(77617-011)

Revised: 1/2022

Document Id: b11dc557-5059-403a-8814-089dcc83c733

34390-5

Set id: 771273ce-68a6-4c29-b3c3-b6a49f33dcdc

Version: 6

Effective Time: 20220124