Label: CAMPHOR, EUCALYPTUS OIL AND MENTHOL ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 14, 2011

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  • ACTIVE INGREDIENT

    Active ingredient                            Purpose

    Camphor 5.2%.............................Cough Suppressant and topical analgesic
    Eucalyptus oil 1.2%......................Cough Suppressant
    Menthol2.8%................................Cough Suppressant and topical analgesic

  • PURPOSE


    Active ingredient                     Purpose

    Camphor 5.2%.............................Cough Suppressant and topical analgesic
    Eucalyptus oil 1.2%......................Cough Suppressant
    Menthol2.8%................................Cough Suppressant and topical analgesic

    Uses
     
    - on chest and throat, temporarily relieves cough due to common cold
    - On muscles and joints, temporarily relieves minor aches and pains
  • KEEP OUT OF REACH OF CHILDREN


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


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

    Warnings

    For external use only; avoid contact with the eyes.

    Do not use

    - by mouth - with tight bandages - in nostrils - on wounds or damaged skin

    Ask a doctor before use if you have

    - cough that occurs with too much phlegm (mucus)
    - persistent or chronic cough such as occurs with smoking, asthma or emphysema.

    When using this product, do not

    - heat  - microwave  - add to hot water or any container
    where heating water.May cause splattering and
    result in burns.


    Stop use and ask a doctor if

    -muscle aches and pains persist for more than 7 days or come back
    - cough lasts for more than 7 days, comes back or occurs with fever, rash or
    persistent headache. These could be signs of a serious condition.

    If pregnant or breast feeding, ask a professional before use.

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


  • DOSAGE & ADMINISTRATION


    Directions

    - See Important warnings under "When using this
    product"

    - Adults and children 2 years and older:

    - rub a thick layer on chest and throat or rub on sore aching muscles
    - cover with a warm, dry cloth if desired
    - keep clothing loose about throat/chest to help vapors reach the nose/mouth
    - repeat up to three times per 24 hours or as directed by a doctor.

    Children under 2 years of age" ask a doctor.

    Other Information

    store at room temperature

  • INACTIVE INGREDIENT


    Inactive Ingredients

    Carbomer 954, cedarleaf oil, cetyl alcohol,
    cetyl palmitate, cyclomethicone copolyol,
    dimethicone copolyol, dimethicone, ETDA,
    glycerin, imidazolidinyl urea, isopropyl palmitate,
    methylparaben, nutmeg oil, PEG-100 stearate,
    propylparaben, purified water, sodium hydroxide,
    stearic acid, thymol, titanium dioxide,
    turpentine oil
  • PRINCIPAL DISPLAY PANEL

    c
  • INGREDIENTS AND APPEARANCE
    CAMPHOR, EUCALYPTUS OIL AND MENTHOL 
    camphor, eucalyptus oil and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-717
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)52 mg  in 1 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL12 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL28 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    THYMOL (UNII: 3J50XA376E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-717-011 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
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