DR. SHEFFIELD VAPOR CREAM- vapor cream cream

Dr. Sheffield Vapor Cream by

Drug Labeling and Warnings

Dr. Sheffield Vapor Cream by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

INGREDIENTS AND APPEARANCE

DR. SHEFFIELD VAPOR CREAM 
vapor cream cream

Product 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)