MUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]

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  • MUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]

MUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]
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NDC 67510-0659-1, 67510-0659-2
Set ID 4ed30556-a6f0-4c23-895b-bdf5e25f06e2
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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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