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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
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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
- Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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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
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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
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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.
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INGREDIENTS AND APPEARANCE
DR. SHEFFIELD VAPOR CREAM
vapor cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 52 mg in 1 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 12 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 28 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-083-54 1 in 1 CARTON 08/01/2013 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/01/2013 Labeler - Sheffield Pharmaceuticals LLC (151177797) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(11527-083)