Label: AMAR VAPORIZING CHEST RUB (camphor- synthetic, eucalyptus oil, and menthol ointment

  • 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 29, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Camphor 5.25%Cough suppressant/topical analgesic
    Eucalyptus oil 1.6%Cough suppressant
    Menthol, natural 3.5%Cough suppressant / topical analgesic
  • Use

    • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
    • temporarily relieves minor aches and pains of muscles and joints
  • Warnings

    For external use only

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts or as occurs with smoking, asthma, or emphysema

    When using this product

    • do not heat
    • do not microwave
    • do not add to hot water or any container where heating water. May cause splattering and result in burns.
    • do not take by mouth or place in nostrils
    • do not get into eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be sings of a serious condition.
    • muscle aches and pains worsen, persist for more than 7 days, or clear up occur again within a few days.

    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 year and over.
    • rub a thick layer on the throat and chest cough, or rub on sore aching muscles or joints
    • cover with a warm, dry cloth if desired
    • clothing should be left loose about the throat and chest to help vapors reach the nose and mouth
    • use up to 3 times daily, or as directed by a doctor
    • children under 2 yeas : ask a doctor
  • Inactive ingredients

    Cedar leaf oil, Nutmeg oil, Turpentine oil, Thymol, White petrolatum

  • PRINCIPAL DISPLAY PANEL - 100g Jar Label

    Amar

    VAPORIZING
    CHEST
    RUB

    3.53 oz (100g)

    Principal Display Panel - 100g Jar Label
  • INGREDIENTS AND APPEARANCE
    AMAR VAPORIZING CHEST RUB 
    camphor (synthetic), eucalyptus oil, and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41499-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)5.25 g  in 100 g
    Eucalyptus Oil (UNII: 2R04ONI662) (Eucalyptus Oil - UNII:2R04ONI662) Eucalyptus Oil1.6 g  in 100 g
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol3.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Nutmeg Oil (UNII: Z1CLM48948) 0.6 g  in 100 g
    Turpentine (UNII: XJ6RUH0O4G)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41499-122-01100 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2010
    Labeler - Amar Remedies Limited - Mumbai (677141751)
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