CHAMPION ULTRA CLEAN- benzalkonium chloride liquid

Champion Ultra Clean by

Drug Labeling and Warnings

Champion Ultra Clean 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

or if condition persist for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help

or contact Posion Control Center right away.

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, Cocamide MIPA, Cocamidopropyl Betaine, Fragrance, Glycerin, Lauryl Polyglucose, Magnesium Nitrate, Maltodextrin, Methylchloroisothiazolinone, Methylisothiazolinone, PEG 150 Distearate, FD&C Red #40, Tetrasodium EDTA, Water, FD&C Yellow #5

Champion Ultra-Clean Antibacterial Liquid Hand Soap

INGREDIENTS AND APPEARANCE

CHAMPION ULTRA CLEAN 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77617-018
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)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
FD&C RED NO. 40 (UNII: WZB9127XOA)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77617-018-02	1 in 1 BOX	03/01/2024
1	NDC: 77617-018-01	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		03/01/2024

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture(77617-018) , api manufacture(77617-018) , pack(77617-018)