HENRY SCHEIN FLEXIBLE UNNA BOOT WITH CALAMINE- zinc oxide, calamine dressing

Henry Schein Flexible Unna Boot with Calamine by

Drug Labeling and Warnings

Henry Schein Flexible Unna Boot with Calamine 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%, Calamine 1%

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: 0404-0011-04

HENRYSCHEIN

MEDICAL BANDAGE

A Flexible Unna Boot With Calamine

BOTA DE UNNA FLEXIBLE CON CALAMINA

Venda Cola de Zinc Cierre con tira de gasa

BOTTE D'UNNA FLEXIBLE AVEC CALAMINE

Bande Unna elastique Gaze tissee

REF 900-7456

Bandage Size/Tomano/Format du pansement/ BandagengroBe/Misura della fascia:

4'' X 10 Yds. (10.2 cm X 9 meters)

INGREDIENTS AND APPEARANCE

HENRY SCHEIN FLEXIBLE UNNA BOOT WITH CALAMINE  
zinc oxide, calamine dressing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25.985 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.015 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: 0404-0011-04	1 in 1 BOX; Type 0: Not a Combination Product	07/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/27/2016

Labeler - Henry Schein, Inc. (012430880)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Le Roy		588387394	manufacture(0404-0011)