Label: TENDERWRAP- 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 29, 2010

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  • 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 12823-401-35

    REF 8035

    tyco/Healthcare

    KENDALL

    TENDERWRAP TM

    Unna Boot Bandage
    with Calamine

    3 in (7.5 cm) x 10 yd (9 m)

    Unna underbensbandage
    med zinkliniment

    Unna Boot verband met
    calamine

    Ligadura de pe Unna
    com Calamina

    Bandage pour botte d'Unna
    a la calamine

    Zinkleimverband mit
    kieselzinkerz

    Fasciatura a stivaletto Unna
    con calamina

    Vendaje Unna Boot
    con calamina

    NON-STERILE / NON-STERILE
    UNSTERIL / NON STERILE
    NO ESTERILIZADO/ OSTERIL
    NIET STERIEL / NAO ESTERILIZADO

    TM Trademark of Tyco Healthcare Group LP or its affiliate.
    TYCO HEALTHCARE GROUP LP
    MANSFIELD, MA 02048
    MADE IN MEXICO

    2010 TYCO HEALTHCARE GROUP LP

    ALL RIGHTS RESERVED 100607
    in U.S. 1-800-962-9888
    www.tycohealthcare.com
    TENDERWRAP 3 INCH WITH CALAMINE LABEL



    NDC 12823-401-36

    REF 8036

    tyco/Healthcare

    KENDALL

    TENDERWRAP TM

    Unna Boot Bandage
    with Calamine

    4 in (10 cm) x 10 yd (9 m)

    Unna underbensbandage
    med zinkliniment

    Unna Boot verband met
    calamine

    Ligadura de pe Unna
    com Calamina

    Bandage pour botte d'Unna
    a la calamine

    Zinkleimverband mit
    kieselzinkerz

    Fasciatura a stivaletto Unna
    con calamina

    Vendaje Unna Boot
    con calamina

    NON-STERILE / NON-STERILE
    UNSTERIL / NON STERILE
    NO ESTERILIZADO/ OSTERIL
    NIET STERIEL / NAO ESTERILIZADO

    TM Trademark of Tyco Healthcare Group LP or its affiliate.
    TYCO HEALTHCARE GROUP LP
    MANSFIELD, MA 02048
    MADE IN MEXICO

    2010 TYCO HEALTHCARE GROUP LP

    ALL RIGHTS RESERVED 100607
    in U.S. 1-800-962-9888
    www.tycohealthcare.com
    TENDERWRAP 4 INCH WITH CALAMINE LABEL
  • INGREDIENTS AND APPEARANCE
    TENDERWRAP 
    zinc oxide, calamine dressing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12823-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE25 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.015 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE0.985 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:12823-401-361 in 1 BOX
    2NDC:12823-401-351 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/29/2010
    Labeler - Tyco Healthcare Group LP (048696421)
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