Bioarpil
FDA Label NDC 54427-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bioarpil Usa, Inc. for the product Bioarpil (NDC 54427-001). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Salicylic Acid 2%

Otc - Purpose

Purpose:

psoriasis and seborrheic dermatitis

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Uses relieves and helps prevent recurrence of skin itching, irritation, redness, flaking, scaling due to psoriasis and seborrheic dermatitis

Warnings

Warnings

  • For external use only
  • Ask a doctor before use if condition covers a large part of the body
  • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
  • Stop use and ask a doctor if condition worsens or does not improve after regular use as directed


Dosage & Administration

Directions

Apply to affected area one to four times daily or as directed by a doctor

Inactive Ingredient

Inactive Ingredients

Alpha-Tocopherol Acetate, Bidens Tripartita Flower Top, Calcium Stearate, Cod Liver Oil, Eucalyptus Oil, Honey, Lavender Oil, Lysozyme Hydrochloride, Matricaria Recutita, Mineral Oil, Petrolatum, Retinol.

Package Label.Principal Display Panel


Product Label (Bio New)

Product Label (Bio New)


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