CASTELLANI PAINT- phenol liquid
Pedinol Pharmacal, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Castellani Paint Modified (colorless)

Drug Facts

Active ingredient

Phenol 1.5%

Purpose

First aid antiseptic

Uses

•: First aid 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.
•: 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.

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.

Keep out of reach of children

Directions

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

Other information

Store at controlled room temperature.

Inactive ingredients

acetone, resorcinol, SD alcohol-40B, water

Questions or comments?

1-800-321-4576

or visit us at www.pedinol.com

PRINCIPAL DISPLAY PANEL - Pedinol Castellani Paint Modified Colorless - 29.57 mL Bottle Label

NDC 0884-2993-01

PEDiNOL®

castellani paint

modified colorless

phenol 1.5%

first aid antiseptic

1 fl. oz. (29.57 mL)

CASTELLANI PAINT
phenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0884-2993
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV)	Phenol	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ACETONE (UNII: 1364PS73AF)
RESORCINOL (UNII: YUL4LO94HK)
ALCOHOL (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0884-2993-01	29.57 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1972	05/04/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/1972	05/04/2021

Labeler - Pedinol Pharmacal, Inc. (064737125)

Name	Address	ID/FEI	Business Operations
Establishment
Cospro Development Corp		785638821	MANUFACTURE(0884-2993)

Revised: 12/2018

Document Id: c8b87ffd-8976-4c99-b844-e938af41df53

Set id: bf6845e5-16f3-4828-bfbf-2bc2596a02f3

Version: 4

Effective Time: 20181203

Pedinol Pharmacal, Inc.