Label: DEEP FRESH ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

  • NDC Code(s): 86815-003-01, 86815-003-02, 86815-003-03, 86815-003-04, view more
    86815-003-05, 86815-003-06, 86815-003-07, 86815-003-08, 86815-003-09, 86815-003-10
  • Packager: AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated April 8, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. BENZALKONIUM CHLORIDE (0.23%, weight/weight (w/w)
    2. Dehydroacetic Acid
    3. Benzoic Acid
    4. Lauryl Glucoside
    5. Glycerin
    6. Propylene Glycol
    7. Etidronate Tetrasodium
    8. Octadecanoıc Acid, (Octadecylimıno)Di-2,1-Ethanediyl Ester
    9. Fatty-Acid Amide Hydrolase 1
    10. Phenoxyethanol
    11. Dicaprylyl Carbonate
    12. Glyceryl Oleate
    13. Polysorbate 20
    14. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Benzalkonium Chloride 0.23% w/w. Purpose: Antibacterial-Antifungal

  • Purpose

    Antibacterial / Antifungal Wet Wipes

  • Use

    Antibacterial Wet Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    Keep away from food and animal feeds. For external use only.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When Using this product do not inhale the vapour or grains of the product if occurs. Do not eat or drink or smoke while using the product. Follow all the instructions to avoid risks on human and environmental health. In case of inhaling: Give fresh air or oxygen. If you feel unwell, consult a doctor. In case of skin contact: This product is produced to contact with the skin. Seek a doctor if redness, swelling, itching, or burning occurs on skin. In case of contact with eyes:If you are wearing contact lenses,remove them immediately.Rinse your eyes with plenty of clean water. In case of swallowing: Rinse mouth. Do not vomiting. If unconscious, never give anything by mouth. If it is vomiting, do not lay it on its back and lay it on its side. Call your local Toxication Center and get medical help.

  • STOP USE

    Seek a doctor if redness, swelling, itching, or burning occurs on skin.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    DIRECTIONS
    Provides practical cleaning without the need of water and soap. It is used for hand cleaning. Open the label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rising required.

  • Other information

    Store the product dry,cool,clean place and keep away from direct sunlight. Keep away from children and pets.

  • Inactive ingredients

    Dehydroacetic Acid, Benzoic Acid, Lauryl Glucoside, Glycerin, Propylene Glycol, Etidronate Tetrasodium, Octadecanoıc Acid, (Octadecylimıno)Di-2,1-Ethanediyl Ester, Fatty-Acid Amide Hydrolase 1, Phenoxyethanol, Dicaprylyl Carbonate, Glyceryl Oleate, Polysorbate 20, Sterile distilled water

  • Package Label - Principal Display Panel

    100 pcs NDC: 86815-003-01

    100 pcs

    15 pcs NDC: 86815-003-02

    15 pcs

    80pcs

    500pcs

    100pcs160pcs

  • INGREDIENTS AND APPEARANCE
    DEEP FRESH ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86815-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.23 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER (UNII: X0S2P50TYC)  
    FATTY-ACID AMIDE HYDROLASE 1 (UNII: E747F394ZQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86815-003-01100 g in 1 POUCH; Type 0: Not a Combination Product03/30/2020
    2NDC:86815-003-0215 g in 1 POUCH; Type 0: Not a Combination Product03/30/2020
    3NDC:86815-003-0480 in 1 CANISTER03/30/2020
    3NDC:86815-003-030.238464 g in 1 PATCH; Type 0: Not a Combination Product
    4NDC:86815-003-06100 in 1 CANISTER03/30/2020
    4NDC:86815-003-050.29808 g in 1 PATCH; Type 0: Not a Combination Product
    5NDC:86815-003-08160 in 1 CANISTER03/30/2020
    5NDC:86815-003-070.4769 g in 1 PATCH; Type 0: Not a Combination Product
    6NDC:86815-003-10500 in 1 CANISTER03/30/2020
    6NDC:86815-003-091.4904 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)
    Registrant - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)
    Establishment
    NameAddressID/FEIBusiness Operations
    AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI365577706manufacture(86815-003)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!