PRODERM- castor oil and balsam peru spray 
Mylan Institutional Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Proderm

Proderm is an aid in the prevention
of and management of decubitus
ulcers when applied in combination
with gentle massage by or under the
direction of professionally trained
personnel.

Active Ingredients

Castor Oil, USP

Balsam Peru

Purpose

Management Decubitus Ulcer

Uses

Management of decubitus ulcers.
Forms protective barrier and speeds healing by increasing capillary
blood flow into the ulcerated area.

     

Warnings

Keep out of reach of children.
For external use only.
Flammable. Do not expose to fire or open flame.
Do not puncture or incinerate can.
Intentional misuse by deliberately concentrating and inhaling the
contents can be harmful or fatal.
Avoid spraying in eyes or nostrils.
Use only as directed.

Directions

Shake can well and hold approximately 12 inches from area to be
treated, press valve and coat rapidly.
Apply three times daily to areas prone to or exhibiting evidence of
tissue breakdown.
PRODERM serves as its own protective barrier; therefore, additional
bandaging is not required.

Other Information

Gentle massage of the area immediately surrounding the problem
area by or under the direction of professionally trained
personnel greatly enhances the effectiveness.
Do not store at temperatures above 120°F.

Inactive Ingredients

Emulsifier and propellants.
(water dispersible)

305.4

Contents: Net Weight 4 oz. (113.4 g). Inert propellant 25% of total content.

UDL Laboratories, Inc.
Rockford, IL 61103

     

PRINCIPAL DISPLAY PANEL

NDC No. 51079-622-82

PRODERM
Topical Dressing

Proderm Topical Dressing Labels
PRODERM 
castor oil and balsam peru spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-622
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CASTOR OIL (UNII: D5340Y2I9G) (CASTOR OIL - UNII:D5340Y2I9G) CASTOR OIL788 mg  in 1 g
BALSAM PERU (UNII: 8P5F881OCY) (BALSAM PERU - UNII:8P5F881OCY) BALSAM PERU87 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-622-82113.4 g in 1 CAN; Type 0: Not a Combination Product09/26/201204/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/26/201204/30/2018
Labeler - Mylan Institutional Inc. (039615992)

Revised: 9/2012
 
Mylan Institutional Inc.