Label: ULTRA STRENGTH PAIN RELIEF BALM ULTRA STRENGTH (camphor- synthetic and 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 November 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Camphor 11%Topical Analgesic
    Menthol 11%Topical Analgesic
  • Uses

    See outer packaging for full uses.

  • Warnings

    For External Use Only

    When using this product

    • Use only as directed
    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds, damaged or irritated skin
    • Do not bandage or cover with wrap or use heating pad
    • Do not use 1 hour prior to bathing or within 30 minutes after bathing.

    Stop use and ask a doctor if

    • Condition worsens
    • Severe skin irritation occurs
    • Pain persists for more than 7 days
    • Pain clears up and then recurs a few days later.

    If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

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

  • Directions

    • For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily
    • For children 12 years of age or younger, consult a doctor before use.
  • Other information

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

  • Inactive Ingredients

    Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil and Paraffin base.

  • Questions

    1-855-314-1850

  • PRINCIPAL DISPLAY PANEL

    bam1bam2

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH PAIN RELIEF BALM   ULTRA STRENGTH
    camphor (synthetic) and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)110 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM110 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    PADANG CASSIA OIL (UNII: 0E15252LIW)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-331-181 in 1 PACKAGE09/10/2020
    118 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/10/2020
    Labeler - Velocity Pharma LLC (962198409)
    Registrant - Velocity Pharma LLC (962198409)
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