COVEX ANTIBACTERIAL HAND SANITIZER, COOL BREEZE- alcohol gel 
DALAN KIMYA ENDUSTRI ANONIM SIRKETI

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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Covex Antibacterial Hand Sanitizer, COOL BREEZE

Drug Facts

Active ingredients

Ethyl Alcohol %60

Purpose

Antibacterial

Uses

Warnings

For external use only: Hands

Flammable, keep away from fire of flame

When using this product.

  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin
  • Do not inhale or ingest

Stop use and ask a doctor if

- irritation and redness develop or if condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

- Wet hands thoroughly with product and allow to dry without wiping  - for children under 6, use only under adult supervision   - not recommended for infants.

Other information

Do not store above 105°F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients:

Water, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance, Sea Salt Extract, Amyl Cinnamal, Limonene, Linalool, Alpha-Isomethyl Ionone, Citral, Geraniol

Package Labeling:

Label

COVEX ANTIBACTERIAL HAND SANITIZER, COOL BREEZE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51209-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.6 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
CITRAL (UNII: T7EU0O9VPP)  
GERANIOL (UNII: L837108USY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51209-012-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/03/2020
Labeler - DALAN KIMYA ENDUSTRI ANONIM SIRKETI (566219285)

Revised: 4/2020
Document Id: a2a153af-ea0c-af59-e053-2a95a90ad11f
Set id: a2a1587e-1ae1-d34b-e053-2995a90a2ce9
Version: 1
Effective Time: 20200406
 
DALAN KIMYA ENDUSTRI ANONIM SIRKETI