Borasol
FDA Label NDC 42333-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Dr. Collado, C X A. for the product Borasol (NDC 42333-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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

Otc - Purpose

Purpose

First Aid Antiseptic

Warnings


Warnings

For external use only

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

Otc - 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.

Otc - Stop Use


Stop use and ask a doctor if

  • the condition worsens, or if symptoms persist for more than 7 days

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

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

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.

Other Safety Information

Other information

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

Inactive Ingredient

Inactive ingredients

boric acid, potassium alum

Otc - Questions

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

Package Label.Principal Display Panel

Borasol (Borasol)

Borasol (Borasol)

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