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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated October 17, 2019

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  • 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 -

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  • INGREDIENTS AND APPEARANCE
    DR SHEFFIELD MUSCLE RUB CREAM 
    muscle rub cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-1624(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 HOMOPOLYMER TYPE C (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:68071-1624-535 g in 1 BOX; Type 0: Not a Combination Product08/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/24/2002
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-1624)