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

  • 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 September 2, 2020

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

  • 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

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    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 finalpart34109/02/2020
    Labeler - CARDINAL HEALTH (097537435)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(70000-0563)