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Sheffield Arthritis and Muscle Pain Relief

Dosage form: cream
Ingredients: CAPSICUM OLEORESIN 0.25mg in 1g
Labeler: Faria LLC dba Sheffield Pharmaceuticals
NDC Code: 11527-089

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 Facts

Active Ingredient

Capsicum Oleoresin 0.025%

Purpose


<Topical analgesic>

Uses
  • For the temporary relief of  minor aches and pains of muscles and joints associated with simple backache, arthritis,strains,bruises and sprains

Warnings


For external use only

Avoid contact with the eyes and mucous membranes

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin.
  • Discontinue use if excessive irritation of skin develops.
  • If pregnant or breast feeding, ask a health professional before use.
  • A temporary burning sensation may occur upon application, but generally disappears in a few days

Keep this and all drugs out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately

Directions
  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • Unless treating hands, wash thoroughly with soap and water immediately after use.

Inactive ingredients

Benzyl Alcohol, Cetyl Alcohol, Glyceryl Sterate, Isopropyl Myristate, Paraffin, PEG-100 Stearate, Petrolatum, Purified Water , Sorbitol

Other Information
  • Store at controlled room temperature 20°- 25°C (68° - 77°F)
  • Close the cap tightly after use

Principal Display Panel – 1.5oz Carton Label

Dr. Sheffield's                  NDC 11527-089-54

SHEAF-FIELD TM

Made in the USA

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

Topical Analgesic

NET WT. 1.5 oz. (43g)

Principal Display Panel – 1.5oz Tube Label

Dr. Sheffield's NDC 11527-089-54

SHEAF-FIELD TM

Made in the USA

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

Topical Analgesic

NET WT. 1.5 oz. (43g)

SHEFFIELD ARTHRITIS AND MUSCLE PAIN RELIEF 
capsicum oleoresin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-089
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM OLEORESIN (CAPSICUM OLEORESIN) CAPSICUM0.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
ISOPROPYL MYRISTATE 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
BENZYL ALCOHOL 
PETROLATUM 
PARAFFIN 
Packaging
#Item CodePackage Description
1NDC:11527-089-541 TUBE in 1 CARTON
143 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/14/2010
Labeler - Faria LLC dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(11527-089)

Revised: 08/2014
 
Faria LLC dba Sheffield Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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