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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 27, 2016

If you are a consumer or patient please visit this version.

View All Sections
  • 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)



    Label
  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!