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NDC 11527-0083-54 Dr. Sheffield Vapor Cream 52; 12; 28 mg/g; mg/g; mg/g Details

Dr. Sheffield Vapor Cream 52; 12; 28 mg/g; mg/g; mg/g

Dr. Sheffield Vapor Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Sheffield Pharmaceuticals LLC. The primary component is CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL.

Product Information

NDC	11527-0083
Product ID	11527-083_188bd230-d6a8-45b5-b1e7-4dce432f26ab
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Dr. Sheffield Vapor Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	Vapor Cream
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	52; 12; 28
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL
Labeler Name	Sheffield Pharmaceuticals LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 11527-0083-54 (11527008354)

Pricing Information	N/A
NDC Package Code	11527-083-54
Billing NDC	11527008354
Package	1 TUBE in 1 CARTON (11527-083-54) / 28 g in 1 TUBE
Marketing Start Date	2013-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 01f1cfce-90da-459a-9fb5-730a5242c57a Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/01/2013

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals LLC		151177797	manufacture(11527-083)

Revised: 4/2016

Document Id: 188bd230-d6a8-45b5-b1e7-4dce432f26ab

Set id: 01f1cfce-90da-459a-9fb5-730a5242c57a

Version: 1

Effective Time: 20160407