Label: ALLURE 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 June 30, 2012

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  • Active Ingredients

    Camphor            4.7%

    Menthol             1.0%

    Eucalyptus Oil   1.0%

  • Purpose

    Decongestant

  • Uses


    • on chest and throat, helps temporarily relive cough due to common cold.
    • on joints and muscles, temporarily relives minor aches and pains.
  • Warnings

    For external use only; avoid contact with eyes.

    Do not use
    • by mouth
    • in nostrils
    • with tight bandages
    • on wounds or damaged skin
  • Ask doctor before use if you have,

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma, emphysema, or smoking
  • When using this product,do not

    • heat
    • microwave
    • add to hot water or any container where heating water. May cause splattering and results in burns
  • Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions
    • muscle aches or pain persist more than 7 days or come back
  • Keep out of the reach of children

    In ingested get medical help or contact a Poison control center immediately
  • Directions

    • adults and children 2 years and over
    • rub a thick layer on chest and throat or rub on sore aching muscles
    • repeat up to 3 times per 24 hours or as directed by doctor
    • do not use on children under 2 years unless directed by doctor

  • Inactive ingredient

    cedar oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil
  • PRINCIPAL DISPLAY PANEL

    ALLURE VAPORISING CHEST RUB
    DECONGESTANT AND COUGH SUPPRESSANT
    4 FL.OZ (113 GRAM)
    PRINCIPAL DISPLAY PANEL



  • INGREDIENTS AND APPEARANCE
    ALLURE VAPORIZING CHEST RUB 
    menthol and camphor and eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.7 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.0 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    THYMOL (UNII: 3J50XA376E)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-003-0850 g in 1 BOTTLE, PLASTIC
    2NDC:52000-003-0956.6 g in 1 BOTTLE, PLASTIC
    3NDC:52000-003-10100 g in 1 BOTTLE, PLASTIC
    4NDC:52000-003-11113 g in 1 BOTTLE, PLASTIC
    5NDC:52000-003-12150 g in 1 BOTTLE, PLASTIC
    6NDC:52000-003-13170 g in 1 BOTTLE, PLASTIC
    7NDC:52000-003-14226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/2012
    Labeler -  Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-003)