Label: RASH BUSTER- zinc oxide paste paste

  • NDC Code(s): 83347-1844-1
  • Packager: Jeshurun Pharmaceutical LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2023

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

  • Use in the specific population

    adult use

  • Inactive ingredients

    Inactive ingredients

  • Dosage and adminstration

    adminstration

  • Precaution section

    precaution

  • Adverse reactions

    Adverse reaction

  • Indication & usage

    indication usage

  • OTC- Active ingredient

    Active ingredients

  • Health claim

    health claim

    Keep out of children

    keep out of children

  • Purpose

    Purpose

  • Ask doctor

    Ask doctor

  • Warnings

    warning

  • LABEL AND DRUG FACTS

    Principal displayRash buster label

  • INGREDIENTS AND APPEARANCE
    RASH BUSTER 
    zinc oxide paste paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83347-1844
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE42.42 g  in 210 g
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM139.629 g  in 210 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN10.857 g  in 210 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    Product Characteristics
    Colorwhite (White Paste) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83347-1844-1210 g in 1 JAR; Type 0: Not a Combination Product05/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/01/2023
    Labeler - Jeshurun Pharmaceutical LLC (092600853)
    Registrant - Jeshurun Pharmaceutical LLC (092600853)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chae Organics, LLC828138375manufacture(83347-1844)