CAMPHOR, EUCALYPTUS OIL AND MENTHOL OINTMENT [CVS]

CAMPHOR, EUCALYPTUS OIL AND MENTHOL OINTMENT [CVS]
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NDC 59779-717-01
Set ID c4d08cc6-e424-40ae-9c9b-5d5b1619377a
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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