Label: MEDICATED CHEST- rub jelly

  • 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 January 1, 2012

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  • ACTIVE INGREDIENT

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

    Purpose
    Cough suppressant + topical analgesic
    Cough suppressant
    Cough suppressant + topical analgesic
  • INDICATIONS & USAGE

    Uses
    •on chest + throat, temporarily relieves cough due to the common cold
    •on muscles and joints, temporarily relieves minor aces and pains
  • WARNINGS

    Warnings
    For external use only; avoid contact with eyes.

    Do not use
    •by mouth •with tight bandages •in nostrils •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 emphusema

    When using this product do not
    •heat •microwave •add to hot water or any container when heating
    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 serious condition.

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of 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 under "When using this product"
    •adults + children 2 yrs + over:
    •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
    •children under 2 years of age: ask a doctor
  • OTHER SAFETY INFORMATION

    Other information •store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients cedar leaf oil, nutmeg oil, special petrolatum, spirits of turpentine, thymol
  • ADVERSE REACTIONS

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN OH 43017
    www.myleader.com
    1-800-200-6313
  • PRINCIPAL DISPLAY PANEL

    Leader
    Chest Rub
    Cough Suppressant
    Topical Analgesic
    NET WT 1.76 oz(50 g)
    label principal display panel
  • INGREDIENTS AND APPEARANCE
    MEDICATED CHEST 
    rub jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-356
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.8 kg  in 100 kg
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 kg  in 100 kg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-356-560.05 kg in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/23/2011
    Labeler - Cardinal Health (097537435)
    Registrant - Vi-Jon (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture
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