MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]

MATA BALM (CAMPHOR, MENTHOL) OINTMENT [AMATA LLC]
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NDC 58167-112-30
Set ID 56f84aae-ea47-4207-80da-3657bc1e0af2
Category HUMAN OTC DRUG LABEL
Packager Amata LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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