Label: NASAL DECONGESTANT- menthol, camphor,eucalyptus oil gel

  • NDC Code(s): 64092-403-04
  • Packager: Great Lakes Wholesale, Marketing, and Sales, INC
  • 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 August 5, 2016

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    GLS PERSONAL CARE SOLUTIONS

    Vaporizing Chest Rub

    Decongestant and cough suppressant

    NET WT. 4 OZ. (110g)

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Menthol 1.0%........................................................................Decongestant

    Camphor 4.7%......................................................................Decongestant

    Eucalytus Oil 1.0%................................................................Decongentant

  • PURPOSE

    Temporarily relieve nasal congestion, chest congestion and cough.

  • INDICATIONS & USAGE

    To temporarily relieve nasal congestion, chest congestion and cough due to the common cold.

    Temporarily relieves minor aches and pains.

  • WARNINGS

    For external use only.

    Not for internal use.

    Avoid contact with eyes.

    Do not put in mouth, notsrils or on wounds or damaged skin.

    Do not use near open flame, in a microwave oven or in a container in which water is being heated, except when adding to cold water in a hot steam vaporizer.

  • PREGNANCY OR BREAST FEEDING

    Consult a physician before use.

  • ASK DOCTOR

    If you have asthma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus.

    If muscle aches persist for more than 7 days or come back, or if cough lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache.

  • KEEP OUT OF REACH OF CHILDREN

    if ingested, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Adults and children 2 years of age and older, rub a 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, loosely 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.

  • DOSAGE & ADMINISTRATION

    Topical decongestant and cough suppressant gel

    1.0% Menthol

    4.7% Camphor

    1.0% Eucalyptus Oil

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    Vaporizing Chest Rub

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    menthol, camphor,eucalyptus oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.17   in 110 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.1   in 110 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.1   in 110 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-403-04110 g in 1 JAR; Type 0: Not a Combination Product06/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/2016
    Labeler - Great Lakes Wholesale, Marketing, and Sales, INC (361925498)
    Registrant - Illinois Industrial Tool, Inc (628032898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan chemical Products Co., Ltd.530766098manufacture(64092-403)