Label: PHOENIX BALM- pain relief rub ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 29, 2011

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  • Active Ingredients

    Camphor 5%.................................... Topical Analgesic
    Menthol 5% ..................................... Topical Analgesic
    Methyl Salicylate 5%........................ Topical Analgesic

  • Purposes

    Topical Analgesic

  • Uses

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

  • WARNINGS

    Warnings    For external use only.

  • When using this product

    • Avoid contact with eyes and mucous 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.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Rub well on the affected area.  Repeat 2 or 3 times daily.
    • For children 2 - 12 years, consult a doctor before use.
  • Other Information

    This product may cause allergic reaction in some people.  Test on small area before use.

  • Inactive Ingredients

    Pine needle oil, Cats Claw and Paraffin Petrolatum

  • PRINCIPAL DISPLAY PANEL

    Phoenix Balm Box FrontPhoenix Balm Box Back

  • INGREDIENTS AND APPEARANCE
    PHOENIX BALM 
    pain relief rub ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24438-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)50 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    CAT'S CLAW (UNII: 9060PRM18Q)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24438-001-021 in 1 BOX
    1NDC:24438-001-0119 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34812/01/2011
    Labeler - Amazonian Naturals, Inc. (969562011)
    Registrant - Amazonian Naturals, Inc. (969562011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amazonian Naturals, Inc.969562011relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Access Trading, SAC953434516manufacture
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