Label: ASSURED VAPORIZING CHEST RUB- menthol camphor 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 March 29, 2019

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  • Active Ingredients

    Camphor 4.7 % Eucalyptus Oil 1% Menthol 2%

  • Purpose

    Decongestant

  • Uses

    • temporarily relieves nasal congestion, chest congestion, and cough due to the common cold
    • temporarily relieves minor aches and pains
  • Warnings:

    FOR EXTERNAL USE ONLY

  • When using this product

    • Avoid contact with eyes
    • Do not put into mouth, nostrils or on wounds or damaged skin
  • Consult a doctor before use if

    • you are pregnant or breast feeding
    • you have ashtma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus
    • If mucus lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache
  • Do not use near

    • open flame
    • microwave oven
    • a container in which water is being heated except when adding cold water to a hot stream vaporizer
  • Keep out of reach of children

    • If ingested, get medical help or contract a Poison Control Center right away
  • Directions

    Adults and children 2 years of age and older

    • rub thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore aching muscles
    • If desired, cover with a soft dry cloth but keep clothing loose
    • repeat up to three times daily especially at bedtime

    Children under 2 years of age

    • consult your physician
  • Inactive Ingredients

    Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil

  • PACKAGE LABEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    ASSURED VAPORIZING CHEST RUB 
    menthol camphor eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51328-2060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.3 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) MENTHOL2.26 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    TURPENTINE OIL (UNII: C5H0QJ6V7F)  
    THYMOL (UNII: 3J50XA376E)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51328-2060-1113 g in 1 JAR; Type 0: Not a Combination Product03/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/21/2019
    Labeler - Royal Exports (650621381)
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