Label: CASTELLANI PAINT- phenol liquid
- NDC Code(s): 58980-820-10
- Packager: Stratus Pharamceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active Ingredient
First Aid AntisepticClose
- First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns
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.
- clean the affected area
- apply a small amount on the area one to three times daily.
- Other Information
Store at controlled room temperature.Close
- Inactive Ingredients
Acetone, Purified Water, Resorcinol, SD alcohol 40B (13%).Close
- Questions or Comments?
1-800-442-7882 or visit us at www.stratuspharmaceuticals.comClose
- SPL UNCLASSIFIED SECTION
Sonar Products, Inc.
Carlstadt, NJ 07072
- PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Box
modified colorless phenol 1.5%
FIRST AID ANTISEPTIC
NET VOL. 1.0 FL OZ (29.57 mL)
- INGREDIENTS AND APPEARANCE
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)