Label: MEDICATED CHEST RUB- camphor, menthol, eucalyptus oil cream

  • Category: HUMAN OTC DRUG LABEL

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 November 29, 2012

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 4.8%
    Menthol 2.6%
    Eucalyptus Oil 1.2%

  • PURPOSE

    Purpose

    Cough suppressant /topical analgesic

    Cough suppressant /topical analgesic

    Cough supressan

  • INDICATIONS & USAGE

    Uses: Temporarily relieves throat and chest

    • cough
    • nasal congestion due to common cold
    • aching muscles
    • minor aches and pains
  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes

  • DO NOT USE

    Do not use:

    • by mouth
    • by nostrils
    • on wounds or damaged skin
    • with light bandages
  • ASK DOCTOR

    Ask a doctor before use if you have

    • asthma
    • excessive phlem (mucus)
    • emphysema
    • persistent or chronic cough
    • cough associated with smoking
  • WHEN USING

    When using this product do not heat
    • microwave
    • use near open flame
    • add to hot water or any container where heating water may cause splattering and result in burns
  • STOP USE

    Stop use and ask a doctor if

    • muscle aches/pain persist more than 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 signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health profesional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out reach of children.

    In case of accidental ingestion get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • see important warnings when using this product
    • children under 2 years of age, ask a doctor before using this product
    • adults and children 2 years older, rub a thick layer on chest and and throat or rub on sore,aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily
  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients:

    cedar leaf oil, nutmeg oil, paraffin, patrolatum, thymol, turpentine oil

  • SPL UNCLASSIFIED SECTION

    image of front label

  • PRINCIPAL DISPLAY PANEL

    Medicated chest rub


    4 oz (113 g)




    image of back label
  • INGREDIENTS AND APPEARANCE
    MEDICATED  CHEST RUB
    camphor, menthol, eucalyptus oil cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.8 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-100-01113 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34807/19/2011
    Labeler - Family Dollar Services Inc (024472631)
    Registrant - Blue Cross Laboratories (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blue Cross Laboratories008298879manufacture(55319-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55319-100)
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