Label: MUSCLE RUB ULTRA- camphor,menthol, methyl salicylate cream

  • NDC Code(s): 67510-0659-1, 67510-0659-2
  • Packager: Kareway Product, Inc.
  • 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 February 17, 2023

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  • Active Ingredients

                           

    Camphor 4%

    Menthol 10%

    Methyl Salicylate 30%


  • Uses

    temporarily relieves the minor aches and pains of muscle and joints associated with:

    • simple bachache
    • 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 of age with arthritis-like conditions

    Ask a doctor before use if you have

    redness over the affected area

    When using this product

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

    Stop use and ask a doctor if

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

    Keep out of reach of children to avoid accidental ingestion.

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

  • Directions

    • Use only as directed

    adults and children 12 years of age and older:

    apply to affected area not more than 3 to 4 times daily

    • children under 12 years of age: ask a doctor
  • Other information

    • Store at 20° to 25°C (68°to 77° F)

  • Inactive Ingredients

    carbomer, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

  • Questions?

    call 1-800-883-0085, weekdays, 9AM -5PM PST

  • PURPOSE

    Topical analgesic

    Topical analgesic

    Topical analgesic

  • PRINCIPAL DISPLAY PANEL

    Muscle Rub Ultra image of carton label

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB ULTRA 
    camphor,menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0659
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-30 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0659-11 in 1 BOX08/11/2011
    135 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67510-0659-21 in 1 BOX08/11/2011
    228 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 finalpart34808/11/2011
    Labeler - Kareway Product, Inc. (121840057)
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