Label: ULTRA STRENGTH PAIN RELIEF BALM- camphor, menthol gel

  • 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 December 28, 2016

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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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