BUTLER CLEAN HANDS- benzalkonium chloride liquid

Butler Clean Hands by

Drug Labeling and Warnings

Butler Clean Hands by is a Otc medication manufactured, distributed, or labeled by Maintex, Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Stop use and ask a doctor if irritation or redness develops

and conditions persist.

Keep out of reach of children.

If swallowed, get medical help

or contact a Posion 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

Aloe Barbadensis Leaf Juice, Caprylyl/Capryl Glucoside, Citric Acid, Cocamidopropyl Betaine, Fragrance, Glycerin, Laurel Polyglucose, Magnesium Nitrate, Maltodextrin, Methylchoroisothiazolinone, Methylisothiazolinone FD&C Red #40, Tetrasodium EDTA, Water, FD&C Yellow #5

Butler Clean Hands

Butler Clean Hands

INGREDIENTS AND APPEARANCE

BUTLER CLEAN HANDS 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77617-004
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77617-004-02	1 in 1 BOX	01/03/2020
1	NDC: 77617-004-01	3.8057 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
OTC Monograph Drug	M	01/03/2020

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture(77617-004) , api manufacture(77617-004) , pack(77617-004)