Label: DR. SHEFFIELD VAPOR CREAM- vapor cream cream

  • NDC Code(s): 11527-083-54
  • Packager: Sheffield Pharmaceuticals LLC
  • 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 April 7, 2016

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  • 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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