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.

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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

Manufactured by:
Sonar Products, Inc.
Carlstadt, NJ 07072

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 Type HUMAN OTC DRUG Item Code (Source) NDC:58980-820
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol 15 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
ACETONE (UNII: 1364PS73AF)  
RESORCINOL (UNII: YUL4LO94HK)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
Color YELLOW (Clear to Yellow) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58980-820-10 1 in 1 BOX
1 29.57 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333A 04/01/2014
Labeler - Stratus Pharamceuticals (789001641)
Establishment
Name Address ID/FEI Business Operations
Sonar Products, Inc. 104283945 MANUFACTURE(58980-820)

Revised: 3/2014
Document Id: e053c409-97b8-4ad6-9edf-4856c1635ac3
Set id: 74192c0e-3c73-4ab0-96d1-1917cbd6777a
Version: 1
Effective Time: 20140326
 
Stratus Pharamceuticals