Label: MUSCLE RUB ULTRA STRENGTH- menthol and methyl salicylate 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 November 14, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Menthol 1% Topical analgesic
    Methyl salicylate 15% Topical analgesic
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  • Use

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
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  • 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.

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  • 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
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  • Other information

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

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

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  • Questions or comments?

    866-323-0107 or www.natureplex.com

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  • 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
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  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB   ULTRA STRENGTH
    menthol and methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 0.01 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.15 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67234-002-01 1 in 1 BOX 01/02/2007
    1 42 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 01/02/2007
    Labeler - Natureplex LLC (062808196)
    Establishment
    Name Address ID/FEI Business Operations
    Natureplex LLC 062808196 MANUFACTURE(67234-002)
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