Label: DR. BROMINE- bromine sanitizer granule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 11, 2020

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  • DOSAGE & ADMINISTRATION

    Store in a cool, dry, ventilated place.

  • INACTIVE INGREDIENT

    Sodium Chloride & Citric Acid

  • INDICATIONS & USAGE

    Please follow the instructions on the package

  • ACTIVE INGREDIENT

    1-BROMO-3-CHLORO-5,5-DIMETHYL-2,4-IMIDAZOLIDINEDIONE

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization

  • WARNINGS

    1.Avoid contact with skin as far as possible, with rubber gloves.
    2.This product has corrosive effect on metal and bleaching effect on fabric.
    3.Store in a cool, dry, ventilated place. Keep away from flammables and fire sources.
    4.It is forbidden to store or transport with strong acids, strong bases and reducing substances.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DR. BROMINE 
    bromine sanitizer granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86179-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    1-BROMO-3-CHLORO-5,5-DIMETHYL-2,4-IMIDAZOLIDINEDIONE (UNII: W18O2G87ND) (1-BROMO-3-CHLORO-5,5-DIMETHYL-2,4-IMIDAZOLIDINEDIONE - UNII:W18O2G87ND) 1-BROMO-3-CHLORO-5,5-DIMETHYL-2,4-IMIDAZOLIDINEDIONE26 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86179-001-01100 g in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/12/2020
    Labeler - LEACHE CHEM LTD (554535701)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEACHE CHEM LTD554535701manufacture(86179-001)