Label: MUSCLE RUB ULTRA STRENGTH- menthol and methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 14, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Menthol 1%Topical analgesic
    Methyl salicylate 15%Topical analgesic
  • Use

    Temporarily relieves minor aches and pains in muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only.

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years old with arthritis-like conditions
    • if seal on tube is punctured or missing

    Stop use and ask a doctor if

    • excessive skin irritation occurs
    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    Ask a doctor before use

    • if the affected area is red
    • if pregnant or breast-feeding
    • for children under 2 years old
    • for children up to 12 years old if prone to allergic reaction from or if sensitive to aspirin or salicylate

    When using this product

    • do not bandage or wrap tightly
    • avoid contact with eyes or mucous membranes

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • use only as directed
    • adults and children 12 years old and older: apply to affected area up to 4 times daily
    • children under 12 years old: ask a doctor
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • close cap tightly after use
  • Inactive ingredients

    Carbomer, cetearyl alcohol and polysorbate 60, cetyl alcohol, glycerin, methylparaben, mineral oil, propylene glycol, propylparaben, purified water, triethanolamine

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton

    Natureplex™

    Ultra Strength
    MuscleRub
    For Minor Arthritis, Backache, Muscle & Joint Pain

    NET WT. 1.5 Oz.
    (42.5g)

    Principal Display Panel - 42.5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB   ULTRA STRENGTH
    menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.01 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-002-011 in 1 BOX01/02/2007
    142 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/02/2007
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-002)
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