Label: VAPORIZING CHEST RUB- menthol and camphor and 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 July 25, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients 

    Camphor 4.7%

    Menthol 1.0%

    Eucalyptus Oil 1.0%

  • Purpose

    Cough suppressant, nasal decongestant & topical analgesic

  • Use:

    Temporarily relives symptoms associated with the common cold:

    • cough
    • nasal congestion
    • chest congestion

    Temporarily relieves minor aches and pains of muscles.

  • Directions:

    See important warning 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.
  • Warnings:

    For external use only: Avoid contact with eyes

    Ask a doctor before use if you have:  

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

    Do not use this product;

    Near an open flame. By adding water. By mouth. In a microwave oven. On wounds or damaged skin. With tight bandages. In nostrils. Added to hot water or any container where you are heating water. May cause splattering and result in burns.

    Stop use and ask a doctor if:

    Muscles aches and pains persist for more than 7 days or come back. Cough lasts more that 7 days comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, consult a physician before use

  • Keep out of reach of children.

    If swallowed, get medical helps or contact a Poison Control Center immediately

  • Inactive Ingredients:

    Petrolatum, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol, Paraffin.

  • Principal Display Panel

    NEW!
    FamilyCare
    Chest Rub
    VAPORIZING ACTION
    Nasal Decongestant
    Cough Suppressant
    NET WT. 4 OZ
    (113g)

    Principal Display Panel FamilyCare Chest Rub

  • INGREDIENTS AND APPEARANCE
    VAPORIZING CHEST RUB 
    menthol and camphor and eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52271-158
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.31 g  in 113 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.13 g  in 113 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.13 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    THYMOL (UNII: 3J50XA376E)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52271-158-01113 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/21/2009
    Labeler - Quality Care Distributors LLC (961937112)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425MANUFACTURE
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