FDA.reportPublic FDA data

Henry Schein Flexible Unna Boot with Calamine

Manufacturer
Henry Schein, Inc. | Laboratorios Le Roy
Effective date
2016-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:24:58

Label at a glance#

ProductHenry Schein Flexible Unna Boot with Calamine
Active ingredientZINC OXIDE, FERRIC OXIDE RED
Label structure7 sections

Indications and 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%, Calamine 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Ask a doctor

OTC - ASK DOCTOR SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Direction

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION


Acacia, Castor oil, Glycerin, and White Petrolatum.


Principal Display Panel

PACKAGE LABEL.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)



Label
Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0404-0011-042025-12-23C16284748780-19d75b9d1-1d10-f424-e053-dadaa90a57ceDrug Facts
0404-0011-042020-01-31C16284748780-19d75b9d1-1d10-f424-e053-dadaa90a57ceDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0011HENRY SCHEIN FLEXIBLE UNNA BOOT WITH CALAMINE (ZINC OXIDE, CALAMINE) DRESSING [HENRY SCHEIN, INC.]1Legacy NDC20160728_0d88365e-46a2-4ddd-bd1b-a2b4fbd3295e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-00110404-0011-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ACACIA5C5403N26OIACT
CASTOR OILD5340Y2I9GIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
FERRIC OXIDE RED1K09F3G675ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
68f9c3d1-4683-4994-aa30-92d9eec7e0870d88365e-46a2-4ddd-bd1b-a2b4fbd3295e2025-12-17WarningsExact identifier
spl set id: 0d88365e-46a2-4ddd-bd1b-a2b4fbd3295e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.