ACTIVEX ANTIBACTERIAL HAND WASH- benzalkonium chloride liquid 
Evyap Sabun Yag Gliserin Sanayi Ve Ticaret 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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Activex Antibacterial Hand Wash

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only

Do not use

in the eyes

Stop use and ask a doctor if

- Irritation and redness develop

- Condition persists for more than 72 hours

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 5mL or palmful to hands and forearms.

- Scrub thoroughly for 30 to 60 seconds.

- Rinse and Repeat.

Other information

- Store in dry and cool place in the original packaging.

- Keep from light including direct sunlight.

Inactive ingredients

Water, glycerin, PEG-4 rapeseedamide, cocamidopropylamine oxide, lauryl glucoside, cetrimonium chloride, PEG-120 methyl glucose dioleate, cocamine oxide, styrene/acrylamide copolymer, lauramine oxide, lauramidopropylamine oxide, malic acid, fragrance, sodium benzoate, myristamidopropylamine oxide, sodium salicylate, phenoxyethanol, sodium chloride, tetrasodium EDTA, sodium PCA.

Questions or comments

1 (224) - 408-0663

Package Labeling:

Label

ACTIVEX ANTIBACTERIAL HAND WASH 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64309-002
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
COCAMINE OXIDE (UNII: QWA2IZI6FI)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
MALIC ACID (UNII: 817L1N4CKP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64309-002-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/01/2020
Labeler - Evyap Sabun Yag Gliserin Sanayi Ve Ticaret Anonim Sirketi (628145740)

Revised: 10/2020
Document Id: b295f92f-3f28-773b-e053-2995a90a62ed
Set id: b295f945-9043-b131-e053-2995a90ad5f6
Version: 1
Effective Time: 20201026
 
Evyap Sabun Yag Gliserin Sanayi Ve Ticaret Anonim Sirketi