ULTRA STRENGTH PAIN RELIEF BALM (CAMPHOR, MENTHOL) GEL [MCCURE HEALTH SOLUTIONS INC.]

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ULTRA STRENGTH PAIN RELIEF BALM (CAMPHOR, MENTHOL) GEL [MCCURE HEALTH SOLUTIONS INC.]
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NDC 52486-013-18
Set ID 0db4294b-4451-4063-a442-bbf3078bc806
Category HUMAN OTC DRUG LABEL
Packager McCure Health Solutions Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active ingredients

    Camphor 11%

    Menthol 11%

    Purpose

    Topical analgesic

  • Uses

    For temporary relief minors aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.

  • Warnings

    For external use only

    When using this product

    • Avoid contact with eyes and mocous membranes
    • Do not apply to open wounds or damaged skin
    • Do not bandage or use heating pad

    Stop use and ask a doctor if

    • Condition worsens
    • Severe skin irritation occurs.
    • Pain persists for more than seven days
    • Pain clears up and then recurs a few days later

    If pregnant or breast-feeding,

    ask a healthcare professional before use

    Keep out of reach of children.

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

  • Directions

    • Rub well on the affected area. Repeat 3 to 4 times daily
  • Other information

    This product may cause allergic reaction in some individuals. Test on small area before use.

  • Inactive ingredients

    CAJUPUT OIL, CLOVE OIL, DEMENTHOLIZED MINT OIL, PARAFFIN PETROLATUMA

  • Product Label

    PAIN RELIEF BALM

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH PAIN RELIEF BALM 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)110 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL110 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52486-013-181 in 1 CARTON03/27/2015
    118 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 finalpart34803/27/2015
    Labeler - McCure Health Solutions Inc. (053034873)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Dedi Medical Device Co., Ltd.544458936manufacture(52486-013)
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