Label: BOROLEUM FOR NASAL SORENESS- camphor, menthol, white petrolatum ointment

  • NDC Code(s): 12090-1235-0, 12090-1235-1
  • Packager: Santus LLC
  • 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 February 7, 2017

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  • Active ingredients

    Camphor 1%

    Menthol 0.54%

    White Petrolatum 97.92%

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  • Purpose

    External analgesic

    External analgesic

    Skin protectant

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  • Uses

    • For the temporary relief of pain and itching associated with minor cuts, scrapes, insect bites, and minor skin irritations (e.g. chafed nose)
    • Temporarily protects minor cuts and scrapes
    • Helps prevent, relieve, and temporarily protect chafed, chapped, or cracked skin

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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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  • Package Labeling
  • INGREDIENTS AND APPEARANCE
    BOROLEUM  FOR NASAL SORENESS
    camphor, menthol, white petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:12090-1235
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.4 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 979.2 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12090-1235-1 17 g in 1 TUBE; Type 0: Not a Combination Product 12/10/2010 12/10/2010
    2 NDC:12090-1235-0 1 in 1 BOX 12/10/2010
    2 17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/10/2010
    Labeler - Santus LLC (079868223)
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