Label: LEADER VAPOR STEAM CAMPHOR (SYNTHETIC) (camphor- synthetic liquid

  • NDC Code(s): 70000-0563-1
  • Packager: LEADER/Cardinal Health 110, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 11, 2024

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  • 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.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • 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

    CAUTION: NOT FOR INTERNAL USE

    NDC 70000-0563-1

    LEADER

    Vapor Steam

    Camphor,6.2%

    Cough Suppressant

    Liquid Medication For Hot Steam Vaporizers

    Temporarily Relieves Steam

    Soothing Menthol Scent

    Compare Vicks® Vapo Steam active ingredient*

    100% Money Back Guarantee

    8 fl oz (237 mL)

    Leader Vapor Steam

  • INGREDIENTS AND APPEARANCE
    LEADER VAPOR STEAM CAMPHOR (SYNTHETIC) 
    camphor (synthetic) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0563
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.062 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    NUTMEG OIL (UNII: Z1CLM48948)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MENTHOL (UNII: L7T10EIP3A)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    ALCOHOL (UNII: 3K9958V90M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0563-11 in 1 CARTON09/02/2020
    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 DrugM01209/02/2020
    Labeler - LEADER/Cardinal Health 110, Inc. (063997360)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(70000-0563)
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