Label: GN MEDI ANTIBACTERIALSPRAY- calcium undecylenate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 30, 2020

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  • Active ingredients

    Calcium undecylenate

  • Purpose

    Antimicrobial

  • Inactive Ingredients

    water, malic acid,Glycine

  • Directions

    it is a violation of Federal law to use this product in a manner inconsistent with its labeling.

    hold container 6"-8" from surface and hands spray until thoroughly wet then allow to air dry.

    our disinfectant can be used to eliminate germs- on commonly touched hard & soft surfaces and also deodorizes places in which it is present by degrading harmful gases in the air.

  • Do not use

    in children less than 2 months of age.

    on open skin wounds

  • when using

    our disinfectant can be used to eliminate germs- on commonly touched hard & soft surfaces and also deodorizes places in which it is present by degrading harmful gases in the air.

  • Stop use and ask a doctor

    in case of eye contact, immediately flush eyes with water. if swallowed, contact physician.

  • WARNINGS

    do not place in direct sunlight or where there may be serve temperature changes.

  • keep out of rech of children

    keep out of rech of children

  • use

    heltha clean disintectant spray kills of the viruses and bacteria your family comes in contact with every day.

    For leather, rayon, acrylic, silk, rayon acetate or satin fabrics, always test on a hidden area of fabric before using.

  • Other information

    This can be carried in a pocket or bag for easy and multiple uses on fabric and products which need to be disinfected.

  • Package Label

    79797-301-01

    79797-301-01

  • INGREDIENTS AND APPEARANCE
    GN MEDI ANTIBACTERIALSPRAY 
    calcium undecylenate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79797-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM UNDECYLENATE (UNII: 77YW1RTU8V) (CALCIUM UNDECYLENATE - UNII:77YW1RTU8V) CALCIUM UNDECYLENATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MALIC ACID (UNII: 817L1N4CKP) 0.2 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) 0.8 g  in 100 g
    GLYCINE (UNII: TE7660XO1C) 0.2 g  in 100 g
    WATER (UNII: 059QF0KO0R) 97.8 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79797-301-01100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/30/2020
    Labeler - GNCOS CO., LTD. (695909963)
    Registrant - GNCOS CO., LTD. (695909963)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ventex Co., Ltd.688813182manufacture(79797-301)
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