CVS VAPOR STEAM (CAMPHOR (SYNTHETIC)) LIQUID [CVS]

CVS VAPOR STEAM (CAMPHOR (SYNTHETIC)) LIQUID [CVS]
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NDC 69842-256-04, 69842-256-08
Set ID 49da2c40-afc5-5770-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Camphor 6.2%

  • Purpose

    Cough suppressant

  • Use

    temporarily relieves cough ocurring with a cold

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    For steam inhalation only.

    Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

    • cough that ocurs 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 if 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. In case of eye exposure, flush with water.

  • Directions

    • see important warnings under "When using this product"
    • adults & children 2 years & over:
    • use 1 tablespoon of solution for each quart of water or 1½ teaspoonful 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
    • breathe in the medicated vapors
    • use up to three times daily or as directed by a doctor
    • children under 2 years: ask a doctor
  • Other information

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

    alcohol (78%), cedarleaf oil, dimethicone, eucalyptus oil, laureth-7, menthol, nutmeg oil, poloxamer 124

  • SPL UNCLASSIFIED SECTION

    Tamper-evident: do not use if the imprinted seal under the cap is broken or missing.

    Keep this carton. It has important information.

  • PRINCIPAL DISPLAY PANEL - 8oz

    CVS Health

    Compare to the active ingredient in Vicks ® VapoSteam ®*

    VAPOR STEAM

    COUGH SUPPRESSANT

    CAMPHOR

    Liquid Medication for Hot Steam Vaporizers

    • Increases the acyion of steam for colds
    • Relieves Cough to Help You Rest

    Soothing Menthol Scent

    CAUTION: NOT FOR INTERNAL USE

    8 fl oz (237 mL)

    pdp

  • INGREDIENTS AND APPEARANCE
    CVS VAPOR STEAM 
    camphor (synthetic) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-256
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.623 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MENTHOL (UNII: L7T10EIP3A)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-256-081 in 1 CARTON07/01/2014
    1236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69842-256-041 in 1 CARTON07/01/2014
    2118 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 finalpart34111/02/2011
    Labeler - CVS (062312574)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(69842-256)

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