Label: BORASOL - eucalyptol, thymol, methyl salicylate and menthol powder 

  • Label RSS
  • NDC Code(s): 42333-100-04
  • Packager: Laboratorios Dr. Collado, C x A.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 05/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients                          Purpose

    Eucalyptol 0.091%                              First Aid Antiseptic
    Thymol 0.063%                                   First Aid Antiseptic
    Methyl Salicylate 0.055%                     First Aid Antiseptic
    Menthol 0.010%                                  First Aid Antiseptic

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  • PURPOSE

    Purpose

    First Aid Antiseptic

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  • WARNINGS


    Warnings

    For external use only

    Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

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  • DO NOT USE


    Do not use:

    • over large areas of the body. In case of deep or puncture wounds, damaged skin, animal bites, or serious burns, consult a doctor
    • longer than 1 week unless directed by a doctor
    • Do not bandage.
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  • STOP USE


    Stop use and ask a doctor if

    • the condition worsens, or if symptoms persist for more than 7 days
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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION


    Directions

    • Clean the affected area
    • Dissolve 2 teasponnfull (10g) in a liter of warm water
    • apply a small amount to the area 3 to 4 times a day
    • For children under 2 years of agea, there is no recommended dosage except under the advice and supervision of a physician
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  • INDICATIONS & USAGE

    Uses:First aid to help prevent infection in minor cuts, scrapes, and burns. For the temporary relief of pain and itching due to minor burns, sunburns, minor cuts, abrasions, insect bites and minor skin irritations.

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  • OTHER SAFETY INFORMATION

    Other information

    Store at controlled room temperature: 15-30 degrees C (59-86 degrees F)

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  • INACTIVE INGREDIENT

    Inactive ingredients

    boric acid, potassium alum

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  • QUESTIONS

    Questions?Laboratorios Dr. Collado Tel: 809-338-7361

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  • INGREDIENTS AND APPEARANCE
    BORASOL 
    eucalyptol, thymol, methyl salicylate, menthol powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42333-100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.091 g  in 100 g
    THYMOL (THYMOL) THYMOL 0.063 g  in 100 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.055 g  in 100 g
    MENTHOL (MENTHOL) MENTHOL 0.01 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BORIC ACID  
    POTASSIUM ALUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42333-100-04 1 in 1 BOX
    1 114 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/01/2013
    Labeler - Laboratorios Dr. Collado, C x A. (871423174)
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