MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.]

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MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.]
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NDC 67510-0005-2, 67510-0005-4
Set ID 0e46fc52-d4e8-48cc-8581-d78a0dd54064
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active ingredient

    Menthol 2.5%

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    For external use only

    Do not use

    • on wound s 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

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

  • Directions

    • 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

    camphor, carbomer 940, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

  • Purpose

    Topical analgesic

  • Package label

    Muscle and joint pain relief rub image of carton label

  • INGREDIENTS AND APPEARANCE
    MUSCLE AND JOINT 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0005-41 in 1 BOX08/11/2011
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67510-0005-21 in 1 BOX08/11/2011
    257 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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