SHEFFIELD ARTHRITIS AND MUSCLE PAIN RELIEF- capsicum oleoresin cream

Sheffield Arthritis and Muscle Pain Relief by

Drug Labeling and Warnings

Sheffield Arthritis and Muscle Pain Relief by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

SHEFFIELD ARTHRITIS AND MUSCLE PAIN RELIEF 
capsicum oleoresin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-089
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY)	CAPSICUM	0.25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-089-54	1 in 1 CARTON	04/14/2010
1		43 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	04/14/2010

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(11527-089)