Castellani Paint Liquid
FDA Label NDC 58980-820

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharamceuticals for the product Castellani Paint (NDC 58980-820). 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

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, Florida 33186

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 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, Purified Water, Resorcinol, SD alcohol 40B (13%).

Questions Or Comments?

1-800-442-7882 or visit us at www.stratuspharmaceuticals.com

Principal Display Panel - 29.57 Ml Bottle Box

NDC 58980-820-10

Castellani Paint

modified colorless phenol 1.5%

STRATUS
PHARMACEUTICALS INC

FIRST AID ANTISEPTIC

NET VOL. 1.0 FL OZ (29.57 mL)

Principal Display Panel (29.57 mL Bottle Box)

Principal Display Panel (29.57 mL Bottle Box)

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