DR SHEFFIELD MUSCLE RUB CREAM- muscle rub cream cream

Dr Sheffield Muscle Rub Cream by

Drug Labeling and Warnings

Dr Sheffield Muscle Rub 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

Menthol - 10%

Methyl salicylate - 15%

Purpose

Topical Analgesic

Topical Analgesic

Uses

• For temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, bruises and sprains

Warnings

For external use only

Avoid contact with eyes and mucous membranes

• If conditions worsens, or if symtoms 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 apply 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 OUT OF REACH OF CHILDREN

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 affected area not more than 3 to 4 times daily. Children under 2 years of age; consult a doctor.
• Unless treating hands, wash hands throughly wit hsoap and waterimmediately after use.

Other information

• Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
• Close cap tightly afteruse.

Inactive ingredients

Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Stearic acid, Triethanolamine, Purified Water

Principal Display Panel - 1.25 oz Carton

Dr. Sheffield's                                     NDC 11527- 057-40

Sheaf-field Trade Mark

MUSCLE RUB Cream

Topical Analgesic

Net WT. 1.25 oz ( 35g)

Principal Display Panel -  1.25 oz Tube

Dr. Sheffield's                                          NDC: 11517-057-40

Sheaf-field Trade Mark

MUSCLE RUB Cream

Topical Analgesic

Net WT. 1.25 oz ( 35g)

INGREDIENTS AND APPEARANCE

DR SHEFFIELD MUSCLE RUB CREAM 
muscle rub cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-057-40	1 in 1 CARTON	04/24/2002
1		35 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	04/24/2002

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(11527-057)