Label: BOROLEUM- camphor, menthol, white petrolatum ointment

  • NDC Code(s): 69618-052-77
  • Packager: Reliable 1 Laboratories
  • 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 March 29, 2023

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  • QUESTIONS

    Questions or comments?:

    516-341-0666

    Boroleum.com

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    CAMPHOR 1%

    MENTHOL 0.54%

    WHITE PETROLATUM 97.92%

  • Purpose

    External analgesic

    External analgesic

    Skin protectant

  • 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 and lips
    • Helps prevent and protect from the drying effects of wind and cold weather
  • 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

    Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns

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

  • 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.

  • Other information

    • Store at room temperature
  • Inactive ingredients

    Eucalyptol, methyl salicylate

  • SPL UNCLASSIFIED SECTION

    Reliable-1 Laboratories LLC Valley Stream NY 11580 Made for Reliable-1 in US

  • PRINCIPAL DISPLAY PANEL

    External Analgestic/Skin Protectant

    Protects in Dry & Cold Climates
    Soothes and Relieves Sore Nose
    Moisturizes Dry Nose
    Chapped Lip Relief
    Use Day or Night

    BOROLEUM®

    FOR NASAL SORENESS

    NDC 69618-052-77

    NET WT 0.6 OZ (17G)

    Boroleum Carton-B

  • INGREDIENTS AND APPEARANCE
    BOROLEUM 
    camphor, menthol, white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM97.92 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.54 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-052-771 in 1 CARTON04/16/2019
    117 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/16/2019
    Labeler - Reliable 1 Laboratories (079718111)
    Registrant - Reliable 1 Laboratories (079718111)
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