Label: MONKEY HOLDING PEACH BRAND EXTERNAL ANALGESIC BALM- camphor,menthol,methyl salicylate 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 April 14, 2014

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  • Active Ingredients

    Camphor              22%

    Menthol               16%

    Methyl Salicylate  3%


  • Purpose

    Topical Analgesic


  • Uses

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


  • Directions

    • Rub well on the affected area. Repeat 3 to 4 times daily.
    • For children 2-12 years, consult a doctor before use.
  • Inactive Ingredients

    Paraffin, Eucalyptus Oil, Cinnamon Oil, Peppermint Oil, Olive Oil.


  • Warnings

    For External Use Only.

    When using this product

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

    Stop use and ask a doctor

    • Condition worsens
    • Severe skin irritation occurs
    • Pain persistes 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.


  • Other information

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


  • Principal Display Panel

    Monkey Holding Peach Brand External Analgesic Balm

    Export USA

    Net Wt. 0.283 fl.oz. (8g)

    NDC 57373-108-01

    Product of Thailand


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    MONKEY HOLDING PEACH BALM EXTERNAL ANALGESIC BALM

    Methyl Salicylate Camphor Menthol Eucalyptus Oil

    Net Wt. 0.42 fl.oz. (12g)

    NDC 57373-108-02

    Product of Thailand


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  • INGREDIENTS AND APPEARANCE
    MONKEY HOLDING PEACH BRAND  EXTERNAL ANALGESIC BALM
    camphor,menthol,methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57373-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)22 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57373-108-018 g in 1 CAN
    2NDC:57373-108-0212 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/14/2014
    Labeler - P.S.W. INC. (802789420)
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