DALAN THERAPY ANTIBACTERIAL HAND WASH, FRESH PROTECTION- benzalkonium chloride liquid 
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.

----------

Dalan Therapy Antibacterial Hand Wash, Fresh Protection

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only: 

When using this product.

  • Do not use in the eyes.

Stop use and ask a doctor if

irritation and redness develop. 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 and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 60 seconds. Rinse and Repeat

Inactive ingredients:

Water, Cocamidopropyl Betaine, Lauryl Amine Oxide, Cocamine Oxide, Cocamidopropylamine Oxide, Sodium Chloride, Glycerine, Lactic Acid, Sodium Lactate, PEG-120 Methyl Glucose Dioleate, Fragrance, Laureth-7 Citrate, Tetrasodium EDTA, Benzophenone-3, Triethylene Glycol, Propylene Glycol, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Limonene, Yellow5, Blue1.

Package Labeling:

Label5

DALAN THERAPY ANTIBACTERIAL HAND WASH, FRESH PROTECTION 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51209-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
COCAMINE OXIDE (UNII: QWA2IZI6FI)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
EDETATE SODIUM (UNII: MP1J8420LU)  
OXYBENZONE (UNII: 95OOS7VE0Y)  
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51209-016-00300 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: a2a1fcb4-e6cd-344c-e053-2a95a90a9496
Set id: a2a1fcab-9d55-4272-e053-2995a90a3bd0
Version: 1
Effective Time: 20200406
 
DALAN KIMYA ENDUSTRI ANONIM SIRKETI