CHAMPION ULTRA CLEAN- chloroxylenol 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Chloroxylenol.......0.3%

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.

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, Cocamidopropyl Betaine, FD&C Red #40, FD&C Yellow #5, Fragrance, Glycerin, Magnesium Nitrate, Maltodextrin, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Sodium Laureth Sulfate, Water

Champion Ultra-Clean Antibacterial Liquid Hand Soap

INGREDIENTS AND APPEARANCE

CHAMPION ULTRA CLEAN 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77617-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	.3 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77617-017-02	1 in 1 BOX	02/06/2020
1	NDC: 77617-017-01	3.8919 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		02/06/2020

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc.		028311595	manufacture(77617-017) , api manufacture(77617-017) , pack(77617-017)