CASTELLANI PAINT- phenol liquid 
Stratus Pharamceuticals

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.

----------

Castellani Paint

Drug Facts

Active Ingredient

Phenol 1.5%

Purpose

First Aid Antiseptic

Uses

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,

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.

KEEP OUT OF REACH OF CHILDREN.

Directions

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

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, Florida 33186

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
CASTELLANI PAINT 
phenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-820
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ACETONE (UNII: 1364PS73AF)  
RESORCINOL (UNII: YUL4LO94HK)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
ColorYELLOW (Clear to Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-820-101 in 1 BOX04/01/2014
129.57 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A04/01/2014
Labeler - Stratus Pharamceuticals (789001641)
Establishment
NameAddressID/FEIBusiness Operations
TARMAC PRODUCTS INC059890491MANUFACTURE(58980-820) , LABEL(58980-820) , PACK(58980-820)

Revised: 10/2017
Document Id: d61f6260-2eae-4911-a499-8bc12abf0b6d
Set id: 74192c0e-3c73-4ab0-96d1-1917cbd6777a
Version: 2
Effective Time: 20171019
 
Stratus Pharamceuticals