Label: BOROLEUM FOR NASAL SORENESS- camphor (synthetic), menthol and petrolatum ointment

  • NDC Code(s): 12090-1235-0, 12090-1235-1
  • Packager: Summit Industries
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • Active ingredients

    Camphor 1%

    Menthol 0.54%

    White Petrolatum 97.92%

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  • Purpose

    External analgesic, skin protectant

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  • Uses

    For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations (e.g. dry nasal passages).

    temporarily protects minor cuts, scrapes, burns

    helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin

    helps prevent and protect from the drying effects of wind and cold weather.

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  • Warnings:

    For external use only

    Avoid contact with eyes.

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

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  • Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns
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  • Keep out of reach of children

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

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  • Directions

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

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  • Other information

    Store at room temperature.

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  • Inactive ingredients

    Eucalyptol, methyl salicylate

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  • Images of Carton and Label

    boroleum_pdp.jpg
    Boroleum PDP
    boroleum_panel.jpg
    Boroleum Panel
    boroleum_tube.jpg
    Boroleum Label
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  • INGREDIENTS AND APPEARANCE
    BOROLEUM  FOR NASAL SORENESS
    camphor, menthol, white petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:12090-1235
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 10 mg  in 1 g
    MENTHOL (MENTHOL) MENTHOL 5.4 mg  in 1 g
    PETROLATUM (PETROLATUM) PETROLATUM 979.2 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    METHYL SALICYLATE  
    EUCALYPTOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12090-1235-0 1 in 1 BOX
    1 NDC:12090-1235-1 17 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 12/10/2010
    Labeler - Summit Industries (003279189)
    Registrant - Summit Industries (003279189)
    Establishment
    Name Address ID/FEI Business Operations
    Summit Industries 003279189 manufacture(12090-1235)
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