RED OIL (MENTHOL AND CAMPHOR) OIL [THE RED OIL COMPANY]

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RED OIL (MENTHOL AND CAMPHOR) OIL [THE RED OIL COMPANY]
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NDC 70537-001-02, 70537-001-08, 70537-001-16
Set ID c19a8705-9478-44ff-9f79-2f275214b0cd
Category HUMAN OTC DRUG LABEL
Packager The Red Oil Company
Generic Name
Product Class
Product Number
Application Number PART341
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  • Actives

    Camphor 1 %

    Menthol 1%

  • Purpose

    External Analgesic

  • SPL UNCLASSIFIED SECTION

  • Indication

    Temporary relief from pain and itiching associated with minor skin irritations , insect bites, minor burns or sun burns, posion oak and minor reactions due to use of soaps, detergents or cosmetics.

  • INACTIVE INGREDIENT

  • Directions

    Apply directly to affected area

    Do not use more than four times per day

  • WARNINGS

  • KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    8 fl oz16 fl oz2fl oz

  • INGREDIENTS AND APPEARANCE
    RED OIL 
    menthol and camphor oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70537-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ACETONE (UNII: 1364PS73AF)  
    WHITE PINE OIL (UNII: HA5CX6676U)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BENZOCAINE (UNII: U3RSY48JW5)  
    CHLOROTHYMOL (UNII: LJ25TI0CVT)  
    PHENOL (UNII: 339NCG44TV)  
    Product Characteristics
    Colorred (D&C Red #17) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70537-001-08237 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/04/2016
    2NDC:70537-001-16473 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/04/2016
    3NDC:70537-001-0259 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/04/2016
    Labeler - The Red Oil Company (011947497)
    Registrant - The Red Oil Company (011947497)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(70537-001)
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