DR. SHEFFIELD VAPOR CREAM (VAPOR CREAM) CREAM [SHEFFIELD PHARMACEUTICALS LLC]

DR. SHEFFIELD VAPOR CREAM (VAPOR CREAM) CREAM [SHEFFIELD PHARMACEUTICALS LLC]
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NDC 11527-083-54
Set ID 01f1cfce-90da-459a-9fb5-730a5242c57a
Category HUMAN OTC DRUG LABEL
Packager Sheffield Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Drug Facts

  • Active Ingredients

    Camphor  5.2%

    Eucalyptus Oil  1.2%

    Menthol 2.8%

  • Purpose

    Cough suppressant and topical analgesic

    Cough suppressant

    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

    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 more than 7 days or come back
    • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headaches. These could be a serious condition.

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

  • WarningsFor external use only; avoid contact with eyes

    Do not use

    • by mouth
    • with tight bandages
    • in nostrils
    • on wounds or danages skin

    Ask 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

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

  • Directionssee important warning under "when using this product."

    • adults and children 2 years and over:
    • 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 doctor
    • children under 2 years: do not use.

    Other information

    Store at controlled room temperature 20°-25°C(68°-77°F)

    Questions

    1-800-222-1087

  • Inactive ingredients

    Carbomer, Cedarleaf oil, Cetyl Alcohol, Cetyl Palmitate, Cyclomethicone, Dimethicone, Disodium EDTA, Glycerin, Imidazolldnyl Urea, Isopropyl Palmitiate, Methylparaben , Nutmeg oil, PEG-100 Sterate, PEG/PPG- 18/18 Dimethicone, Propylparaben, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Thymol, Titantium Dioxide, Purfied Water

  • Principal display Panel 1.0 oz Carton

    Dr. Sheffield's                                             NDC 11527-083-54

    SHEAF-FIELD TM

    Greaseless

    Vapor Cream 

    Cough Suppressant Topical Analgesic

    made in the USA                                            NET WT. 1oz. (28g)

    Principal display Panel 1.0 oz Carton

  • Principal display Panel 1.0 oz Tube

    Greaseless medicated cream vapors work quickly to help relieve coughs

    Dr. Sheffield's NDC 11527-083-54

    SHEAF-FIELD TM

    Greaseless

    Vapor Cream

    Cough Suppressant Topical Analgesic

    made in the USA NET WT. 1oz. (28g)

    See drug info below: Failure to follow these warnings could result in serious consequences.

    Principal display Panel 1.0 oz Tube

  • INGREDIENTS AND APPEARANCE
    DR. SHEFFIELD VAPOR CREAM 
    vapor cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)52 mg  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL12 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL28 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IMIDUREA (UNII: M629807ATL)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    THYMOL (UNII: 3J50XA376E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-083-541 in 1 CARTON08/01/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2013
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-083)

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