PC529 ULTREX- chloroxylenol soap 
CARROLL COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Chloroxylenol 0.25% w/w

Purpose

Antimicrobial

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Uses

Hand washing in public washrooms, work areas, healthcare facilities,

ofice buildings, food service facilities, and wherever cleanliness and

antimicrobial properties are desired.

Warnings

For external use only

When using this product

Directions

 apply small amount of product to hands.  hold hands under water and work cleaner into lather.   rinse hands with water and wipe clean.

Other information

 store at room temperature

 recommended for use in Wall Mount Dispenser

Inactive ingredients:

Water, Potassium Cocoate, TEA Cocoyl Hydrolyzed Collagen, hydroxyethyl Cellulose, Glycol Distearate, Sodium Laureth Sulfate, Myristyl Alcohol, Cocamidopropyl Betaine, Sodium Chloride, C9-11 Pareth-6, Fragrance, Propylene Glycol, Tetrasodium EDTA, Isopropyl Myristate, FD & C Red #40, D &C Red #33, Methylchloroisothiazolinone (and) Methylisothiazolinone.

PRINCIPAL DISPLAY PANEL - 800 mL Bag Label

CLEAN N FRESH®

Ultrex
Antimicrobial
Hand Soap

800 ml

CARROLL®
Company
Garland, TX 75041

image description

PC529 ULTREX 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10685-529
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
C9-11 PARETH-6 (UNII: KCE0V8JT7W)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10685-529-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/21/2014
2NDC:10685-529-17800 mL in 1 BAG; Type 0: Not a Combination Product01/21/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/21/2014
Labeler - CARROLL COMPANY (007372329)

Revised: 1/2018
Document Id: 6416fa98-1660-1068-e053-2a91aa0acdca
Set id: fbf4cfcd-b826-40c7-a344-b9846a61c8cf
Version: 2
Effective Time: 20180131
 
CARROLL COMPANY