Label: DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL- alcohol gel

  • NDC Code(s): 86815-002-01, 86815-002-02, 86815-002-03, 86815-002-04, view more
    86815-002-05
  • 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) 70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (0.5% v/v).
    3. Carbomer (0.35% v/v).
    4. Triethanolamine (0.1% v/v).
    5. 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)

    Alcohol 70% v/v. Purpose: Antibacterial

  • Purpose

    Antibacterial Hand Gel

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from fire,flame,sparks and heat. Keep away from children, food and animal feeds.

  • Do not use

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

    Do not inhale the vapour or grains of the product if occurs. In case of inhaling: If you feel uncomfortable get some fresh air.In case of contact with eyes:If you are wearing contact lenses, remove them immediately.Rinse your eyes with plenty of clean water. Seek for medical advice if necessary. In case of swallowing: Rinse the patient's mouth with water and drink water. Keep it calm. Do not induce vomiting. Call your local Toxication Center and get medical help.

  • 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

    Take some Antibacterial gel in your hand. Rub your hands, between the fingers, all the inner and outer surfaces, the nails, until they dry. It is used for hand cleaning. Do not rinse after use.

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, Carbomer, purified water USP, Triethanolamine

  • Package Label - Principal Display Panel

    1000 mL NDC: 86815-002-04

    1000 ML

    2500 mL NDC: 86815-002-05

    2500 ML

    500 mL NDC: 86815-002-01

    500 ML

    100 mL NDC: 86815-002-02

    100 ML

    200 mL NDC: 86815-002-03

    200 ML

  • INGREDIENTS AND APPEARANCE
    DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86815-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 1342 (UNII: 809Y72KV36) 0.35 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.05 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86815-002-041000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    2NDC:86815-002-052500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    3NDC:86815-002-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    4NDC:86815-002-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    5NDC:86815-002-03200 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(86815-002)
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