Label: THERA WISE NATURAL VAPOR RUB (camphor- natural ointment

  • NDC Code(s): 43347-172-01
  • Packager: Derma Wise Skin Care Ltd.
  • 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 July 19, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Camphor Oil 4.8%

  • Purpose

    Cough suppressant

  • Uses

    • Temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
    • Alleviates cough to help you get to sleep.
  • Warnings

    For external use only

    • Do not take by mouth or place in nostrils.
    • Avoid contact with eyes, wounds or damaged skin.
    • Wash hands thoroughly after use.

    Combustible: Keep away from fire or flames

    Do not use this product for persistent chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

    Stop use and consult a doctor if cough:

    • persists for more than 1 week
    • tends to recur
    • is accompanied by fever, rash or persistant headache

    A persistent cough may be a sign of a serious condition.

    When using this product do not

    • heat
    • microwave
    • use near open flame
    • add to hot water or container where heating water

    May cause splattering and result in burns.

    Keep out of reach of children.

  • Directions

    See warnings under "When using this product".

    • For use in adults and children 2 years and older.
    • Rub on the throat and chest as a thick layer
    • Cover with a warm dry cloth if desired.
    • Clothing should be left loose about the throat and chest to help vapours reach the nose and mouth.
    • Use up to three times daily or as directed by your doctor.
    • For use in children under 2 years of age: please consult a doctor or attending physician
  • Other information

    • Store between 2° and 25° C (35° - 77° F)
    • Do not use if seal is broken
  • Inactive ingredients

    Argan Kernel Oil, Bitter Orange Oil, Castor Seed Oil, Eucalyptus Leaf Oil1, Hydrogenated Olive Oil, Olive Fruit Oil, Olive Oil Unsaponifiables, Olive Squalane, , Peppermint Leaf Oil, Pine Needle Oil1, Rhus Verniciflua Peel Wax, Rose Hip Seed Oil1, Sunflower Seed Oil, Thyme Oil.


    1
    Certified Organic
  • Questions or Comments?

    Call weekdays 9am to 5pm PST @ 1.888.488.1808

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Box

    THÉRA WISE®

    Natural Vapor Rub
    4.8 % CAMPHOR OIL, OINTMENT

    Temporarily relieves cough due to minor throat
    and bronchial irritation associated with a cold

    WITH EUCALYPTUS LEAF, CAMPHOR BARK,
    PINE NEEDLE AND THYME LEAF OIL,
    ROSE HIP SEED & ARGAN OIL

    NET WT 1OZ (28g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Box
  • INGREDIENTS AND APPEARANCE
    THERA WISE NATURAL VAPOR RUB 
    camphor (natural) ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43347-172
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1.344 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    Argan Oil (UNII: 4V59G5UW9X)  
    Bitter Orange Oil (UNII: 9TLV70SV6I)  
    Castor Oil (UNII: D5340Y2I9G)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Hydrogenated Olive Oil (UNII: 53839415GI)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Olea Europaea (Olive) Oil Unsaponifiables (UNII: XO45V955LT)  
    Squalane (UNII: GW89575KF9)  
    Mentha Piperita Leaf (UNII: A389O33LX6)  
    Pine Needle Oil (Pinus Sylvestris) (UNII: 5EXL5H740Y)  
    Toxicodendron Vernicifluum Fruit Rind Wax (UNII: 6RG2461FCH)  
    Rosa Moschata Oil (UNII: J99W255AWF)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Thyme Oil (UNII: 2UK410MY6B)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43347-172-011 in 1 BOX08/15/2016
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/15/2016
    Labeler - Derma Wise Skin Care Ltd. (242166531)