Label: ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION (camphor- synthetic, levomenthol, eucalyptus ointment

  • NDC Code(s): 80591-001-01
  • Packager: AYUSHREE PHARMACEUTICALS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 28, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredient                        Purpose

    Camphor 5.00% ......................... Cough suppressant, nasal decongestant & topical analgesic

    Menthol 2.60% .......................... Cough suppressant, nasal decongestant & topical analgesic

    Eucalyptus Oil 1.20% .................. Cough suppressant, nasal decongestant & topical analgesic

  • PURPOSE

  • Use

    Temporarily relieves symptoms associated with the common cold:

    • cough
    • nasal congestion
    • chest congestion

    Temporarily relieves minor aches and pains of muscles.

  • Warnings

    For external use only. Avoid contact with eyes.
    Ask a doctor before use if you have

    • Cough with excessive phlegm (mucus)
    • Chronic cough that lasts or as occurs with smoking, asthma or emphysema.

    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.

    • Muscle aches and pains persist for more than 7 days or come back.
    • Cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be sign of a serious condition

    If pregnant or breast-feeding, consult a physician before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    See important warnings under "Do not use this product".

    • Children under 2 years of age, ask a doctor.
    • Adults and children 2 years of age or older: Rub a thick layer on chest and throat. If desired. loosely cover with a soft dry cloth but keep clothing loose.
    • Repeat up to 3 times daily, or as directed by a doctor.
  • Inactive ingredients

    BHT, Cedar Oil, Hard Wax, Light Liquid Paraffin, Micro Wax, Nutmeg Oil, Pine Oil, Thymol.

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION 
    camphor (synthetic), levomenthol, eucalyptus ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80591-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL2.6 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    WHITE PINE OIL (UNII: HA5CX6676U)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80591-001-01113 g in 1 DRUM; Type 0: Not a Combination Product09/28/202002/28/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/28/202002/28/2024
    Labeler - AYUSHREE PHARMACEUTICALS PRIVATE LIMITED (861375952)
    Establishment
    NameAddressID/FEIBusiness Operations
    AYUSHREE PHARMACEUTICALS PRIVATE LIMITED861375952manufacture(80591-001)