Castellani Paint
FDA Label NDC 54868-0127

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Castellani Paint (NDC 54868-0127). 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 other, active ingredient, purpose, uses, warnings, do not use, otc - stop use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Phenol 1.5%

Purpose

First Aid Antiseptic

Uses

  • First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns

Warnings

For external use only

Do Not Use

  • in eyes
  • with bandages
  • on large areas of the body
  • longer than one week unless directed by a doctor
  • stop use and consult a doctor if condition persists
  • in case of deep puncture wounds, animal bites, or serious burns, consult a doctor
  • if known to be sensitive to any ingredients in this product,

Otc - Stop Use

Stop use and ask a doctor or pharmacist if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.

When Using This Product

  • check skin for sensitivity to phenol prior to application.
  • care should be taken to avoid spilling and guard against staining. Castellani Paint Modified will stain skin and clothing.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Directions

  • clean the affected area
  • apply a small amount on the area one to three times daily.

Other Information

Store at controlled room temperature.

Inactive Ingredients

Acetone, basic violet 14 (basic fuchsine), resorcinol, SD alcohol 40B (13%), water.

Questions Or Comments?

1-800-PEDiNOL (733-4665) or visit us at www.pedinol.com

Principal Display Panel - 29.57 Ml Bottle Label


PEDiNOL™

castellani paint

modified with color

phenol 1.5%

first aid antiseptic

net vol. 1 fl. oz. (29.57 ml)

Castellani Paint Bottle Label 29.57 mL (3aa69d68 7a22 4a55 9682 Ecc14540984a 01)

Castellani Paint Bottle Label 29.57 mL (3aa69d68 7a22 4a55 9682 Ecc14540984a 01)


Distributed by:

Physicians Total Care, Inc.

Tulsa, OK  74146

NDC 54868-0127-0

Package Label (0127)

Package Label (0127)

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