Label: MUSCLE RUB CREAM- menthol 10%, methyl salicylate 15% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredient

    Menthol 10%

  • Active Ingredient

    Methyl Salicylate 15%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

  • Warnings

    For external use only

    Do not use:

    •
    On wounds or damaged, broken, (open) or irritated skin
    •
    With a heating pad

    Ask a doctor before use if you are pregnant or breast feeding.

    When using this product

    •
    Avoid contact with eyes or mucous membrane
    •
    Do not bandage tightly
  • Stop Use and ask a doctor

    •
    Conditions worsens or does not improve within 7 days
    •
    Symptoms clear up and occur again within a few days
    •
    Excessive skin irritation develops

    A temporary burning sensation may occur upon application, but generally disappears in a few days

  • Keep out of the reach of Children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    •
    Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

    Children under 12 years of age. consult a doctor

    •
    Unless treating hands, wash hands thoroughly with soap and water immediately after use.
  • Other Information

    •
    Store at controlled room temperature 20º-25ºC (68º-77ºF)

    Questions ? Call 1-888-296-9067

  • Inactive Ingredients

    Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

  • Distributed By

    Trifecta Pharmaceuticals USA, LLC.

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301

    www.trifecta-pharma.com

    Made in China

    This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson consumer companies Inc. owner of the registered trademark BENGAY®.

    Relabeled By: Preferred Pharmaceuticals Inc.
    NDC 68788-8544-8

  • Packaging

    Muscle Rub
  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB CREAM 
    menthol 10%, methyl salicylate 15% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8544(NDC:69396-110)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8544-81 in 1 BOX11/06/2023
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug34811/06/2023
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8544)
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