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  5. Label Information: Tenderwrap

FDA Label for Tenderwrap

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNING
    5. DIRECTIONS
    6. OTHER INGREDIENTS
    7. PRINCIPAL DISPLAY PANEL

Tenderwrap Product Label

The following document was submitted to the FDA by the labeler of this product Tyco Healthcare Group Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 the managing extremities (e.g. varicose ulcers) requiring protection and support.

Warning



  • Keep out of reach of children.
    • For external use only.
      • When using this product do not get into eyes.
        • Stop use and ask a doctor if:
          •                 ● conditions worsens
                          ● symptoms last more than 7 days
                          ● clear up and occur again within a few days.


Directions



  • 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 the leg.
  • Complete bandaging to just below the knee and apply an adhesive elastic bandage to secure the Unna Boot.
  • Re-apply as needed

Other Ingredients



Acacia, Castor oil, Glycerin, and White Petrolatum.


Principal Display Panel



NDC 12823-401-35REF 8035tyco/HealthcareKENDALLTENDERWRAP TMUnna Boot Bandagewith Calamine3 in (7.5 cm) x 10 yd (9 m)Unna underbensbandagemed zinklinimentUnna Boot verband metcalamineLigadura de pe Unnacom CalaminaBandage pour botte d'Unnaa la calamineZinkleimverband mitkieselzinkerzFasciatura a stivaletto Unnacon calaminaVendaje Unna Bootcon calaminaNON-STERILE / NON-STERILEUNSTERIL / NON STERILENO ESTERILIZADO/ OSTERILNIET STERIEL / NAO ESTERILIZADOTM Trademark of Tyco Healthcare Group LP or its affiliate.TYCO HEALTHCARE GROUP LPMANSFIELD, MA 02048MADE IN MEXICO2010 TYCO HEALTHCARE GROUP LPALL RIGHTS RESERVED 100607in U.S. 1-800-962-9888www.tycohealthcare.comNDC 12823-401-36REF 8036tyco/HealthcareKENDALLTENDERWRAP TMUnna Boot Bandage with Calamine4 in (10 cm) x 10 yd (9 m)Unna underbensbandage med zinklinimentUnna Boot verband met calamineLigadura de pe Unna com CalaminaBandage pour botte d'Unna a la calamineZinkleimverband mit kieselzinkerzFasciatura a stivaletto Unna con calaminaVendaje Unna Boot con calaminaNON-STERILE / NON-STERILEUNSTERIL / NON STERILENO ESTERILIZADO/ OSTERILNIET STERIEL / NAO ESTERILIZADOTM Trademark of Tyco Healthcare Group LP or its affiliate.TYCO HEALTHCARE GROUP LPMANSFIELD, MA 02048MADE IN MEXICO2010 TYCO HEALTHCARE GROUP LPALL RIGHTS RESERVED 100607in U.S. 1-800-962-9888www.tycohealthcare.com

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