Label: EARTHS BEST COLD RELIEF VAPOR- camphor, menthol, eucalyptus globulus leaf oil ointment

  • 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 May 23, 2012

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  • ACTIVE INGREDIENT

    Camphor                                   5.3%

    Menthol                                     2.8%

    Eucalyptus Globulus Leaf Oil      1.3%

  • PURPOSE

    Natural Skin Protectant

  • INDICATIONS & USAGE

    • Temporarily relieves cough due to common cold
    • On muscles and joints, temporarily relieves minor aches and pains
  • WARNINGS

    For external use only. Avoid contact with eyes. Do not take by mouth or place in nostrils. Ask a doctor before use if you have cough with too much phlegm (mucus)or persistent or chronic cough such asthma. When using this product do not heat, microwave, add to hot water or any container where heating water. May cause splattering and result in burns.  Stop use and ask doctor if  muscle aches and pains persist more than 7days or come back,cough lasts more than 1 week, comes back or occurs with fiver, rash or persistent headache. There could be signs of serious condition. If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

  • DOSAGE & ADMINISTRATION

    See important warnings under "When using this product". Adults and children 2 years old and older:
    • Rub over chest and throat in a thick layer or rub on aching muscles.
    • Cover with warm dry cloth if desired.
    • Keep clothing loose around chest and throat  to help vapors to reach nose and mouth.
    • Use up to 3 times per day or as directed by doctor. Children under 2 years of age : Ask a doctor.
  • INACTIVE INGREDIENT

    Helianthus Annuus (Sunflower) Seed Oil *, Beeswax*, Mentha Piperita (Peppermint) Oil*

    * Certified Organic Ingredients
  • QUESTIONS

    Questions? Visit  www.earthsbest.com or call 877-527-6801

  • PRINCIPAL DISPLAY PANEL

    image of jar label        image of carton label

  • INGREDIENTS AND APPEARANCE
    EARTHS BEST COLD RELIEF VAPOR 
    camphor, menthol, eucalyptus globulus leaf oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0758
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5.3 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.8 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0758-21 in 1 CARTON
    180 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/13/2011
    Labeler - The Hain Celestial Group, Inc (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc858894996manufacture
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