Label: MUSCLE RUB- menthol, camphor, 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 July 1, 2014

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  • Active Ingredient

    Active Ingredient                                  Purpose

    Natural Menthol USP 10%                     Topical analgesic

    Methyl salicylate  30%                           Topical analgesic

    Camphor 4%                                         Topical analgesic                                 

  • Purpose

    Temporary relief of minor aches and pains.

  • Indications and Usage

    Uses

    Temporary relief of minor aches and pains of sore muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • Warnings

    For external use only.

    • Avoid contact with the eyes or mucous membranes.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.
    • Do not use with heating pad or device.
  • Stop Use

    Stop Use And Ask A Doctor If:

    • Condition worsens, or if symptoms persist for more than 7 days,
    • symptoms clear up and occur again in a few days
    • redness is present or excessive skin irritation develops

    If pregnant or breast feeding:

    Ask a health professional before use.

  • Keep Out Of Reach Of Children

    KEEP OUT OF REACH OF CHILDREN

    If accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • Dosage & Administration

    Directions

    • Use only as directed
    • Adults and children 12 years of age and older: apply to the affected areas not more than 3 or 4 times daily.
    • Children under 12 years of age: Consult a physician.
  • Other Information

    Store at 20° - 25°C (68°-77°F)

  • Inactive Ingredients

    Acrylates/C-10-30 alkyl acrylates, benzyl alcohol, carbomer, polysorbate 80, trolamine, water.

  • Principle Display Panel

    Blossom Pharmaceuticals Muscle Rub

    blossom mrub.jpg

    Blossom Pharma Muscle Rub

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB 
    menthol, camphor, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-406
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)40 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61767-406-0185 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2014
    Labeler - Blossom Pharmaceuticals (677381470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceuticals677381470manufacture(61767-406)
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