Label: VAPORIZING CHEST RUB- menthol camphor eucalyptus oil gel

  • 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 September 20, 2009

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredients 

    Menthol             1.0%

    Camphor       4.7%

    Eucalyptus Oil       1.0%

     

  • Purpose

    Decongestant

  • USE:

    To temporarily relieve nasal congestion, chest congestion and cough due to the common cold. Temporarily relieves minor aches and pains.

  • Warnings:

    For external use only. Not for internal use. Avoid contact with eyes. Do not put in mouth, nostrils or on wounds or damaged skin.

    If pregnant or breast feeding:

    Consult a physician before use. Do not use near open flame, in a microwave oven or in a container in which water is being heated except when adding to cold water in a hot steam vaporizer.

    Consult a physician before use:

    If you have asthma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus. If muscle aches persist more than 7 days or comes back or if cough lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache.

    Keep out of reach of children.

    If ingested get medical help or contact a Poison Control Center right away.

  • Directions:

    Adults and children 2 years of age and older rub a thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, aching muscles. If desired, loosely cover with a soft dry cloth but keep clothing loose. Repeat up to three times daily, especially at bedtime. Children under 2 years of age, consult your physician.

  • Inactive Ingredients:

    Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil.

  • Principal Display Panel

    Vaporizing Chest Rub

    Decongestant & Cough Suppressant

    NET WT. 4 OZ. (110g)

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    VAPORIZING CHEST RUB 
    menthol camphor eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34954-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (UNII: 5TJD82A1ET) (CAMPHOR - UNII:5TJD82A1ET) CAMPHOR4.7 g  in 110 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.1 g  in 110 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.1 g  in 110 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    NUTMEG (UNII: AEE24M3MQ9)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    THYMOL (UNII: 3J50XA376E)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34954-014-04110 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/21/2009
    Labeler - Kim Chemicals LTD (650470164)
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