Label: VAPORIZING CHEST- camphor, menthol, eucalyptus salve

  • Category: HUMAN OTC DRUG LABEL

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 November 21, 2011

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  • ACTIVE INGREDIENT



    Active Ingredients

    Camphor 4.7%

    Menthol 1.0%

    Eucalyptus Oil 1.0%

  • PURPOSE



    Purpose   Cough Suppressant

  • KEEP OUT OF REACH OF CHILDREN



    Do not use on children under 2 years unless directed by doctor

  • DOSAGE & ADMINISTRATION



    Directions

    adults and children 2 years and over;

    rub a thick layer on chest and throat or rub on sore aching muscles;

    keep clothing loose around chest/throat to help vapors reach the nose/mouth;

    repeat up to 3 times per 24 hours or as directed by doctor;

    do not use on children under 2 years unless directed by doctor


  • INACTIVE INGREDIENT



    Inactive ingredients

    cedar leaf oil, mineral oil, nutmeg oil, petrolatum, thymol, turpentine oil.

  • WARNINGS



    Warnings

    For external use only, avoid contact with eyes.

    Do not use by mouth, in nostrils, with tight bandages, on wounds or damaged skin

    Ask doctor before use if you have,

    cough that occurs with too much phlegm (mucus

    persistent or chronic cough such as occurs with asthma, emphysema, or smoking

    When using this product, do not
    heat
    microwave
    add to hot water or any container where heating water. May cause splattering and results in burns.

    Stop use and ask a doctor if
    cough lasts more than 7 days comes back, or occurs with fever, rash or persistent headache.

    These could be signs of a serious conditions.
    muscle aches and pain persist more than 7 days or come back.
  • INDICATIONS & USAGE


    Uses on chest and throat, helps temporarily relieve, decrease, suppress, quiet and alleviate cough as may occur with common cold and minor bronchial irritation.
  • PRINCIPAL DISPLAY PANEL

    label


    Personal Care

    Vaporizing Chest Rub Cough Suppressant

    Net Wt. 4 oz (113 g)

  • INGREDIENTS AND APPEARANCE
    VAPORIZING CHEST  
    camphor, menthol, eucalyptus salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.31 g  in 113 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.13 g  in 113 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.13 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9033-1113 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2011
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo United Group Co Ltd528196956manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Prodcuts Co, Ltd530766098manufacture
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