VAPORX BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL) OINTMENT [GERITREX LLC]

VAPORX BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL) OINTMENT [GERITREX LLC]
PDF | XML

NDC 54162-450-50
Set ID 093ed58c-0813-4c56-acd7-e6ac35d44449
Category HUMAN OTC DRUG LABEL
Packager Geritrex LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • 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)

Related Drugs