CND COOL BLUE- alcohol gel 
COLOMER MEXICO

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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DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 62%

PURPOSE

Antiseptic Handwash

USE

  • For handwashing to decrease bacteria on skin.

WARNING

  • For external use only.
  • Flammable. Keep away from heat or flame.

  • When using this product

  • Do not use near eyes.
  • Do not use on broken skin.

  • Stop use and ask a doctor if, irritation and redness occurs and persists for 72 hours.

  • Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

DIRECTIONS

  • Before each nail service, wet hands thoroughly with product. Briskly rub hands together until dry.

INACTIVE INGREDIENTS

Aqua, Isopropyl Alcohol, Hydroxyethylcellulose, Fragrance (Parfum), Blue 1 (CI 42090).

PRINCIPAL DISPLAY PANEL - 236 mL bottle label

CND™

ESSENTIALS

CoolBlue™

Hand Sanitizer

236 mL (8 fl oz)

PRINCIPAL DISPLAY PANEL - 236 mL bottle label
CND COOL BLUE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44847-9000
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL0.62 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:44847-9000-1236 mL in 1 BOTTLE, DISPENSING
2NDC:44847-9000-2975 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A03/31/200905/15/2013
Labeler - COLOMER MEXICO (824594886)
Establishment
NameAddressID/FEIBusiness Operations
COLOMER MEXICO824594886MANUFACTURE, PACK

Revised: 09/2011
Document Id: 81971dda-28b0-416e-b2f6-f689857b593c
Set id: c787b085-a844-4eaa-983e-6eda01c074b0
Version: 2
Effective Time: 20110926
 
COLOMER MEXICO