Champion Ultra Clean by Maintex Champion Ultra Clean

Champion Ultra Clean by

Drug Labeling and Warnings

Champion Ultra Clean by is a Otc medication manufactured, distributed, or labeled by Maintex. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHAMPION ULTRA CLEAN- chloroxylenol 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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Champion Ultra Clean

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

Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Glycerine, Fragrance, Aloe Vera, FD&C Yellow #5, FD&C Red #40 

Champion Ultra-Clean Antibacterial Liquid Hand Soap

CHAMPION ULTRA CLEAN 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77617-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	13 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77617-013-02	1 in 1 BOX	02/06/2020
1	NDC: 77617-013-01	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	01/10/2024

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc.		028311595	manufacture(77617-013) , api manufacture(77617-013) , pack(77617-013)

Revised: 1/2024

Document Id: ca6dbf2e-08a3-4ee1-844b-bee804648603

34390-5

Set id: 7f74d3b9-ecab-4a56-be04-71a65b89244d

Version: 6

Effective Time: 20240110