TENDERWRAP- zinc oxide, calamine dressing

TENDERWRAP by

Drug Labeling and Warnings

TENDERWRAP by is a Otc medication manufactured, distributed, or labeled by Tyco Healthcare Group LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

TENDERWRAP 
zinc oxide, calamine dressing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12823-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	25 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.015 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	0.985 g

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12823-401-36	1 in 1 BOX
2	NDC: 12823-401-35	1 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/29/2010

Labeler - Tyco Healthcare Group LP (048696421)