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 August 24, 2017

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  • Drug Facts
  • Active Ingredients

    Menthol - 10%

    Methyl salicylate - 15%

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  • Purpose

    Topical Analgesic

    Topical Analgesic

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  • Uses

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

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  • 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.

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  • 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.
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  • Other information

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

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

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  • Principal Display Panel - 1.25 oz box
  • INGREDIENTS AND APPEARANCE
    DR SHEFFIELD MUSCLE RUB CREAM 
    muscle rub cream cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-1624(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:68071-1624-5 35 g in 1 BOX; Type 0: Not a Combination Product 08/24/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 04/24/2002
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    Name Address ID/FEI Business Operations
    NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-1624)
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