Label: VAPORX BALM- camphor, eucalyptus oil, menthol 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 December 30, 2015

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  • Active Ingredients:

    Camphor 4.8%
    Eucalyptus Oil 1.2%
    Menthol 2.6%

  • Purpose:

    Camphor - Cough Suppressant and Topical Analgesic
    Eucalyptus Oil- Cough Suppressant
    Menthol- Cough Suppressant and Topical Analgesic 

  • Uses:

    - On chest and throat, 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 USE

    Do not use: - by mouth - with tight bandages
    - in nostrils - damaged skin or open wounds

  • Ask your doctor before use if you have:

    - Persistent or chronic cough such as occurs with smoking, asthma or emphysema. - If excessive mucous present

  • When using this product, do not:

    - heat - microwave - add to hot water or any container with heating water.
    May cause splattering and result in burns 

  • Stop use and ask doctor if:

    - muscle aches and pains persists more than 7 days
    - cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
    These could be signs of a serious condition

  • If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children, if swallowed, get medical help or contact a Poison Control center right away 

  • Directions:

    - Adults and children 2 years and over
    - Rub a thick layer on chest & throat or rub on sore aching muscles
    - Cover with warm, dry cloth if desired.
    - Keep clothing loose around throat/chest to help vapors reach the nose and mouth
    - repeat up to three times per 24 hours or as directed by doctor 

  • STORAGE AND HANDLING

    Other Information: Store at room temperature

  • Inactive Ingredients:

    nutmeg oil, modified petrolatum, thymol, turpentine oil

  • QUESTIONS

    Questions? 1-800-736-3437

  • PRINCIPAL DISPLAY PANEL

    Vaporx Balm

  • INGREDIENTS AND APPEARANCE
    VAPORX BALM 
    camphor, eucalyptus oil, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.4 g  in 50 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.6 g  in 50 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.3 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    NUTMEG OIL (UNII: Z1CLM48948)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-450-5050 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/29/2015
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-450)
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