Label: ULTRA STRENGTH PAIN RELIEF BALM- camphor menthol ointment ointment

  • 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 March 20, 2017

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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Camphor 11%........................................................ Topical analgesic

    Menthol 11%.......................................................... Topical analgesic

  • PURPOSE

    Uses

    For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arhtritis, strains, and spraings

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

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

    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
  • ASK DOCTOR

    If pregnant or breast feeding, ask a healthcare professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed get medical help or contact a Poison Control Center immediately

  • INDICATIONS & USAGE

    Directions

    • Rub well on the affected area. Repeat 3 to 4 times dailys.
    • For children 2-12 years, consult a doctor before use
  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    cajuput oil, clove oil, dementholized mint oil, paraffin petrolatuma

  • DOSAGE & ADMINISTRATION

    Distributed by:
    MCURE HEALTH SOLUTIONS INC.
    20819 Currier Rd #200
    City of Industry, CA 91789
    Made in China

  • PRINCIPAL DISPLAY PANEL

    PAIN RELIEF BALM

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH PAIN RELIEF BALM 
    camphor menthol ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CLOVE OIL (UNII: 578389D6D0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52486-320-1818 g in 1 BOTTLE; Type 0: Not a Combination Product03/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/20/2017
    Labeler - MCURE HEALTH SOLUTIONS (053034873)
    Establishment
    NameAddressID/FEIBusiness Operations
    Suzhou Vastech Medical Technology Co., Ltd543772485manufacture(52486-320)
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