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Proderm

Mylan Institutional Inc.

Proderm


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Proderm 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

Proderm

castor oil and balsam peru SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51079-622
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
castor oil 788 mg
BALSAM PERU 87 mg

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51079-622-82 113.4 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-09-26


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