Label: MATA BALM- camphor, menthol 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 May 11, 2013

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  • Active Ingredient

    Camphor 4.5%

    Menthol 37%

  • Purpose

    Topical  Analgesic 

  • Keep out of reach of children

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

  • Uses

    For temporarily relief of pain and itching associated with insect bites,minor skin irritations and infections,

    rashes, boils, minor aches and pains of muscles and joints, dizziness

  • Warnings

    For external use only

    When using this product

    • Use only as directed
    • Do not apply to wounds and broken skin
    • Avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • severe skin irritation occurs
    • symptoms persist for more than 7 days or clear up and reoccur within a few days
  • Directions


    Apply thin layer to or rub gently upon the desired area or inhale as needed. Repeat 3 to 4 times daily. For infants under 12 months of age, consult physician before use


  • Inactive Ingredients


    Aloe Vera, Barleria Lupulina, Beach Morning Glory, Betel leaf, Clinacanthus Nutans Lindau, Coconut oil, Crinum Veld Lily, Garden Quinine, Paraffin, Petrolatum,Zingiber Cassamunar.


  • STORAGE AND HANDLING


    Other Information:

    This product may cause allergic reaction in some individuals, test on small area before use

    Store at 68° to 85°F (20° to 30°C)


  • PRINCIPAL DISPLAY PANEL

    Drug Label

  • INGREDIENTS AND APPEARANCE
    MATA BALM 
    camphor, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58167-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)45 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL367 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BARLERIA PRIONITIS WHOLE (UNII: 8GSN1J79JM)  
    IPOMOEA PES-CAPRAE FLOWERING TOP (UNII: 0SJ345C829)  
    PIPER BETLE LEAF (UNII: NT24A1359E)  
    CAJANUS CAJAN LEAF (UNII: DP2IW63584)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    QUININE (UNII: A7V27PHC7A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ZINGIBER MONTANUM FLOWERING TOP (UNII: P614KWN5QY)  
    CRINUM ASIATICUM WHOLE (UNII: 4A0W54S52I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58167-112-301 in 1 BOX
    130 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/27/2013
    Labeler - Amata LLC (078743307)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sopa Suthayalai661732799manufacture(58167-112)
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