Label: DR SHEFFIELD MUSCLE RUB CREAM- muscle rub cream cream

  • NDC Code(s): 11527-057-40
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

If you are a consumer or patient please visit this version.

  • 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

    Sheffield    Pharmaceuticals                             NDC 11527- 057-40

    MUSCLE RUB Cream

    Menthol 10%, Methyl Salicylate 15%

    Topical Analgesic

    Net WT. 1.25 oz ( 35g)

    Principal Display Panel - 1.25 oz Carton

  • Principal Display Panel -  1.25 oz Tube

    Sheffield Pharmaceuticals NDC 11527- 057-40

    MUSCLE RUB Cream

    Menthol 10%, Methyl Salicylate 15%

    Topical Analgesic

    Net WT. 1.25 oz ( 35g)

    Principal Display Panel - 1.25 oz Tube

  • INGREDIENTS AND APPEARANCE
    DR SHEFFIELD MUSCLE RUB CREAM 
    muscle rub cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-057-401 in 1 CARTON04/24/2002
    135 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/24/2002
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-057)