GENERATIONS ANTIMICROBIAL- chloroxylenol soap 
Cole Papers

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 0.3% w/w

Purpose

Antimicrobial

Keep out of reach of children

If swallowed, get medical attention or contact a poison control center immediately.

Uses

Warnings

For external use only

When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Directions

 wet hands  apply small amount of product and work into a lather   rinse well and dry hands completely

Inactive ingredients:

Water, Sodium laureth sulfate, Sodium chloride, Cocamidopropyl betaine, PEG-120 Methyl glucose dioleate, DMDM hydantoin, Linear alcohol ethoxylate, Propylene glycol, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Tetrasodium EDTA, Isopropyl myristate, Citric acid, FD&C Red #40, FD&C Red #33.

PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label

GENERATIONS
The Power of Experience Since 1918

Antimicrobial Lotion Soap

Keep out of reach of children.
CAUTION:
See back panel for additional precautions.

NET CONTENTS: 1 U.S. GALLON (3.78 LITERS)

image description

GENERATIONS ANTIMICROBIAL 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69554-524
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
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)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69554-524-283785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/26/2015
Labeler - Cole Papers (006221444)

Revised: 1/2015
Document Id: c07015a3-ac43-4b2d-8f79-de7c528a362b
Set id: 926a07fb-9556-4676-96d2-70b62b010c59
Version: 1
Effective Time: 20150126
 
Cole Papers