HENRY SCHEIN FLEXIBLE UNNA BOOT WITH CALAMINE  - zinc oxide, calamine dressing 
Henry Schein, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Zinc Oxide 25%, Calamine 1%

Purpose

Skin Protectant

Uses

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



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)



Label
HENRY SCHEIN FLEXIBLE UNNA BOOT WITH CALAMINE  
zinc oxide, calamine dressing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25.985 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.015 g
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CASTOR OIL (UNII: D5340Y2I9G)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0011-041 in 1 BOX; Type 0: Not a Combination Product07/27/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/27/2016
Labeler - Henry Schein, Inc. (012430880)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Le Roy 588387394manufacture(0404-0011)

Revised: 7/2016
Document Id: 9bc69799-0327-4c8c-9db4-0f47bb14c684
Set id: 0d88365e-46a2-4ddd-bd1b-a2b4fbd3295e
Version: 1
Effective Time: 20160727
 
Henry Schein, Inc.