FRESH DETOX ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
AQUA KOZMETIK DIS 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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Fresh Detox Antibacterial Wet Wipes

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

Warnings

For external use only

Do not use 

  • in children less than 2 years of age
  • on open skin wounds
  • if you are allergic to any of the ingredients

When using this product 

do not get into eyes. In case of contact, rinse eyes thoroughly with water for 15-20 minutes. Remove contact lenses, if present.

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

Other information

Inactive ingredients

water, peg 7glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, phenoxyethanol, dehydroacetic acid, benzoic acid, fragrance, edetate sodium, citric acid

Questions?

You may also report serious side effects to this mail adress? 

info@aquakozmetic.com.tr

Package Labeling:

Label

FRESH DETOX ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79997-001
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)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79997-001-0180 in 1 BOX01/15/2021
12.875 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/15/2021
Labeler - AQUA KOZMETIK DIS TICARET ANONIM SIRKETI (595758242)

Revised: 12/2020
Document Id: b7b11f40-db75-401c-e053-2a95a90a6605
Set id: b7b12a16-eea2-d6a2-e053-2a95a90a0b86
Version: 1
Effective Time: 20201230
 
AQUA KOZMETIK DIS TICARET ANONIM SIRKETI