Champion Ultra Clean by Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. Champion Ultra Clean

Champion Ultra Clean by

Drug Labeling and Warnings

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

Drug Details [pdf]

CHAMPION ULTRA CLEAN- chloroxylenol liquid 
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.

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 Antibacterial Liquid Hand Soapimage description

CHAMPION ULTRA CLEAN 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50241-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50241-002-021 in 1 BOX01/06/2020
1NDC: 50241-002-013.8919 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/06/202002/06/2020
Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
Establishment
NameAddressID/FEIBusiness Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(50241-002) , api manufacture(50241-002) , pack(50241-002)

Revised: 2/2020
Document Id: e8ce1193-60ea-4772-a536-5cee3171dde7
Set id: d7ef8022-73c3-448b-a019-c2e84e86c409
Version: 2
Effective Time: 20200206
 
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.