HENRY SCHEIN FLEXIBLE UNNA BOOT- zinc oxide dressing

Henry Schein Flexible Unna Boot by

Drug Labeling and Warnings

Henry Schein Flexible Unna Boot by is a Otc medication manufactured, distributed, or labeled by Henry Schein, Inc., Laboratorios Le Roy . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 25%

Purpose

Skin Protectant

Uses

• Dries the oozing and weeping of poison ivy, poison oak, or poison sumac.
• Ideal for managing extremities (e.g., varicose ulcers) requiring protection and support.
  

Warning

For external use only.

Avoid contact with eyes.

Ask a doctor

If condition worsens or does not improve within 7 days, consult a doctor

Keep out of reach of children

Keep this and all medicines out of children's reach.

Direction

• Begin bandaging at base of toes, without pressure, keeping foot and leg at right angle. Continue bandaging beyond ankle, doubling back to ensure molding to contours of leg (STEP 1)

• Complete bandaging to just below the knees (STEP 2).

• Apply an elastic adhesive bandage (STEP 3).

Other Ingredients

Acacia, Castor oil, Glycerin, and White Petrolatum.

Principal Display Panel

NDC: 0404-0009-03

HENRYSCHEIN

MEDICAL BANDAGE

A Flexible Unna Boot

BOTA DE UNNA FLEXIBLE

Venda Cola de Zinc Cierre con tira de gasa

BOTTE D'UNNA FLEXIBLE

Bande Unna elastique Gaze tissee

REF 100-3444

Bandage Size/Tomano/Format du pansement

3'' X 10 Yds. (7.6 cm X 9 meters)

INGREDIENTS AND APPEARANCE

HENRY SCHEIN FLEXIBLE UNNA BOOT  
zinc oxide dressing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0009-03	1 in 1 BOX; Type 0: Not a Combination Product	06/06/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/06/2016

Labeler - Henry Schein, Inc. (012430880)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Le Roy		588387394	manufacture(0404-0009)