Label: VAPORIZING CHEST RUB- menthol camphor eucalyptus oil gel

  • 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 March 6, 2010

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  • SPL UNCLASSIFIED SECTION

    Label for

    NOVA PETROLEUM & CHEMICALS CORP.

    Vaporizing Chest Rub

    Drug Facts:

  • Active Ingredients:

    Camphor 4.7%

  • Purpose:

    Cough suppressant & topical analgesic

  • Active Ingredients:

    Menthol1.0%            

  • Purpose:

    Cough suppressant & topical analgesic

  • Active Ingredients:

    Eucalyptus Oil 1.0%     

  • Purpose:

    Cough suppressant

  • Use:

    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 by mouth, with tight bandages, in nostrils or on wounds or damaged skin.

  • Ask a doctor before use if you have:

    Cough that occurs with too much phlegm (mucus); persistent or chronic cough such 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.

  • Stop use and ask a doctor if:

    Muscle aches and pains persist more than 7 days or come back.

    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: 

    See important warnings under “When using this product”

    Adults and children 2 years and older:

    Rub a thick layer on chest & throat or rub on sore, aching muscles.

    Cover with a warm, dry cloth if desired.

    Keep clothing loose about throat/chest to help vapors reach the nose/mouth.

    Repeat up to three times per 24 hours or as directed by doctor.

    Children under 2 years of age: ask a doctor.

  • Other information:

    Store at room temperature.

    Made in India

    Imported by:

          Nova Petroleum & Chemicals Corp.

          Roethal Drive Suite 1 D

          Hopewell Junction, NY 12533

          www.novawax.com

    Distributed by:

          Vini Health and Beauty Products Inc.

          3 Roethal Drive Suite 1 D

          Hopewell Junction, NY 12533

  • Principal Display Panel

    Sofskin 
    Topical Analgesic 
    Cough Suppressant 
    Vaporizing 
    Chest Rub 
    NET WT 3.53 OZ (100 g)

    Principal Display Panel Sofskin Vaporizing Chest Rub Net Wt 3.52 Oz (100 g)

  • INGREDIENTS AND APPEARANCE
    VAPORIZING CHEST RUB 
    menthol camphor eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52069-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR, (+/-)- (UNII: 5TJD82A1ET) (CAMPHOR, (+/-)- - UNII:5TJD82A1ET) CAMPHOR, (+/-)-4.7 g  in 110 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.1 g  in 110 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.1 g  in 110 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52069-101-04110 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/10/2010
    Labeler - Nova Petroleum & Chemicals Corporation (831871731)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kim Chemicals LTD650470164MANUFACTURE
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