VAPORIZING (CAMPHOR) INHALANT [VI-JON]

VAPORIZING (CAMPHOR) INHALANT [VI-JON]
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NDC 11344-397-34
Set ID f239d7d9-c8f9-4464-b27b-b45997dad898
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • safety information

    FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES

  • Active Ingredient

    Camphor 6.2%

  • Purpose

    Cough suppressant

  • Use

    temporarily relieves cough associated with a cold

  • Warnings

    For external use only

    For steam inhalation only. Do not take by mouth.

  • Flammable

    • keep away from fire or flame.
  • Ask a doctor before use if you have

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

    • heat
    • microwave
    • use near an open flame
    • take by mouth
    • direct steam from the vaporizer too close to the face
    • add to hot water or any container where heating water except when adding to cold water only in a hot steam vaporizer. May cause splattering and result in burns.

  • Stop use and ask a doctor

    cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

  • 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 & children 2 years and older: use 1 tablespoon of solution for each quart of water or 1 1/2 teaspoons of solution for each pint of water
    • add solution directly to cold water only in a hot steam vaporizer
    • follow manufacturer's directions for using vaporizer
    • breath in medicated vapors
    • may be repeated up to 3 times a day
    • children under 2 years: ask a doctor
  • Other information

    • close container tightly and store at room temperature away from heat
  • Inactive ingredients

    alcohol 82%, dimethicone, eucalyptus globulus leaf oil, laureth-7, menthol, Myristica fragrans (nutmeg) kernel oil, poloxamer 124, Thujka occidentalis leaf oil (cedar leaf oil)

  • Disclaimer

    This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks Vapo Steam

  • Adverse reactions section

    DISTRIBUTED BY: Vi-Jon., St. Louis, MO 63114

    Questions or Comments? 1-888-593-0593

    Made in the USA

    with US and foreign parts

    397.002/397AA Rev 2

  • principal display panel

    SWAN

    MEDICATED

    VAPORIZING

    STEAM LIQUID

    Liquid Medication for

    Hot Steam Vaporizers

    • COUGH SUPRESSANT
    • FONTAINS FAMPHOR mm3.jpg
    • RELIEVE COUGH TO HELP YOU REST
    • RELIEF OF THROAT AND BRONCHIAL IRRITATIONS

    CAUTION: NOT FOR INTERNAL USE

    DO OT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    Compare to Vicks Vapor Steam Active Ingredients

    8 fl oz (237 mL)

    image description

  • principal display panel

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    mountain

    falls

    *Compare to

    Vicks Vapo Steam

    relieves cough to help you rest

    liquid

    medication

    for hot steam

    vaporizers

    vaporizing

    steam liquid

    cough suppressant

    CAUTION: NOT FOR INTERNAL USE

    Do not use if printed seal under cap is broken or missing

    8 FL OZ (237 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    VAPORIZING 
    camphor inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-397
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)62 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MENTHOL (UNII: L7T10EIP3A)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-397-341 in 1 CARTON10/03/2012
    1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/03/2012
    Labeler - Vi-Jon, LLC (150931459)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11344-397)

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