Label: DEEPFRESH ANTIBACTERIALSOAP- benzalkonium chloride soap

  • NDC Code(s): 86815-005-01, 86815-005-02, 86815-005-03
  • 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 January 23, 2022

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  • 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% w/v) ( active ingredient )
    2. Glycerol (2 % v/v)
    3. Lauramine Oxide (1,5 % v/v)
    4. Disodium Cocoamphodiacetate (2 % v/v)
    5. Hexylene Glycol (1 % v/v)
    6. Sodium Chloride (0.4% v/v)
    7. PEG-150 Distearate (3% v/v)
    8. Cocamidopropyl Betaine (5% v/v)
    9. Cetrimonium Chloride (0.3% v/v)
    10. Magnesium Nitrate (0.0018% v/v)
    11. Methylchloroisothiazolinone and Methylisothiazolinone (0.0014% v/v)
    12. Tetrasodium EDTA (0.03% v/v)
    13. Citric Acid (0.05% v/v)
    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/v. Purpose: Antibacterial / Antifungal

  • Purpose

    Antibacterial / Antifungal, Hand Sanitizer

  • Use

    Antibacterial Liquid Soap helps to reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only.

  • Do not use

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

    This product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • Wet your hands with clean water.Take some Deepfresh Antibacterial liquid soap and foam it. Thoroughly rub your hands between fingers,all inside and outside surfaces,nails. Rinse your hands with clean water.
  • Other information

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

    Glycerol, Lauramine Oxide, Disodium Cocoamphodiacetate, Hexylene Glycol, Sodium Chloride, PEG-150 Distearate, Cocamidopropyl Betaine, Cetrimonium Chloride, Magnesium Nitrate, Methylchloroisothiazolinone and Methylisothiazolinone, Tetrasodium EDTA, Citric Acid, Sterile distilled water or boiled cold water.

  • Package Label - Principal Display Panel

    2500 ml1000 ml500 ml

  • INGREDIENTS AND APPEARANCE
    DEEPFRESH ANTIBACTERIALSOAP 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86815-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.23 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HEXYLENE GLYCOL (UNII: KEH0A3F75J) 1 mL  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.4 mL  in 100 mL
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 5 mL  in 100 mL
    DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F) 2 mL  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.05 mL  in 100 mL
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) 3 mL  in 100 mL
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W) 1.5 mL  in 100 mL
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.3 mL  in 100 mL
    MAGNESIUM NITRATE (UNII: 77CBG3UN78) 0.0018 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 84.49 mL  in 100 mL
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) 0.03 mL  in 100 mL
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.0014 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86815-005-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    2NDC:86815-005-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    3NDC:86815-005-032500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    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(86815-005)
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