Label: CAMPHOR liquid

  • Category: HUMAN OTC DRUG LABEL

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 February 16, 2011

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  • ACTIVE INGREDIENT

    Active ingredient                            Purpose
    Camphor 6.2%.............................Cough Suppressant
  • PURPOSE


    Active ingredient                     Purpose
    Camphor 6.2%..................Cough Suppressant
    ______________________________________

    Uses temporarily relieves cough due to minor throat
    and bronchial irritation associated with a cold.
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get
    medical help or contact a Poison Control Center immediately.
  • INDICATIONS & USAGE

    Uses - temporarily relieves cough due to minor throat
    and bronchial irritation associated with a cold.
  • WARNINGS

    Warnings
    If pregnant or breastfeeding consult a healthcare
    professional before use
    ___________________________________________________

    Flammable Keep away from fire or flame
    _____________________________________________

    - for steam inhalation only - do not take by mouth
    ____________________________________________________

    Ask a doctor before use if you have a persistent or
    chronic cough such as occurs with smoking, asthma, or
    emphysema, or if cough is accompanied by excessive
    phlegm (mucus)
    _____________________________________________________

    When using this product do not
    - heat  - microwave  - use near an open flame
    - 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 persists for more than one (1) week, tends to
    recur, or is accompanied by fever, rash or persistent
    headache. A persistent cough may be a sign of a
    serious condition
    ______________________________________________________

    Keep out of reach of children. If swallowed, get
    medical help or contact a Poison Control Center
    immediately
    ______________________________________________________

  • DOSAGE & ADMINISTRATION


    Directions
    - See Important warnings under "When using this
    product"

    - Adults and children 2 years and older:
        use 1 tablespoon of solution directly for each quart
        of water or 1-1/2 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
        - Breath in medicated vapors
        - use up to 3 times daily or as directed by a doctor
    - For use with children under 2 years of age:
        ask a doctor
    ________________________________

    Other information - Close container tightly and
    store at room temperature away from heat
  • INACTIVE INGREDIENT

    Inactive Ingredients Dimethicone, Eucalyptus
    Globulus (Encalyptus Oil) Leaf Oil, Laureth-7, Menthol,
    Mys=ristica Fragrans (nutmeg) Kernal Oil, Poloxarner 124,
    SD Alcohol 40-B, Thuja Occidentalis (Cedar Leaf) Oil,
    Lavandula Angustifolia (Lavender) Oil
  • PRINCIPAL DISPLAY PANEL

    label
  • INGREDIENTS AND APPEARANCE
    CAMPHOR 
    camphor liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-058
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)155 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MENTHOL (UNII: L7T10EIP3A)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-058-011 in 1 CARTON
    1237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/19/2009
    Labeler - CVS (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture