MUSCLE RUB (MENTHOL, CAMPHOR, METHYL SALICYLATE) CREAM [DYNAREX CORPORATION]

MUSCLE RUB (MENTHOL, CAMPHOR, METHYL SALICYLATE) CREAM [DYNAREX CORPORATION]
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NDC 67777-406-01
Set ID 318c8d1c-4e97-4090-bdaa-3b1220292858
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART348
  • 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 acrylate, benzyl alcohol, carbomer, polysorbate 80, trolamine, water.

  • Principle Display Panel

    Dynarex Muscle Rub

    dynarex mrub.jpg

    Dynarex Muscle Rub

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB 
    menthol, camphor, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-406
    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:67777-406-0185 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2014
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceuticals677381470manufacture(67777-406)

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