Country: United States
Language: English
Source: NLM (National Library of Medicine)
Zinc Oxide 25%
Henry Schein, Inc.
TOPICAL
OTC DRUG
Skin Protectant - 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.
OTC monograph final
HENRY SCHEIN FLEXIBLE UNNA BOOT - ZINC OXIDE 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._ ---------- DRUG FACTS ACTIVE INGREDIENTS Zinc Oxide 25% PURPOS E Skin Protectant US ES 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 0404-0009-03 HENRYSCHEIN MEDICAL BANDAGE A Flexible Unna Boot BOTA DE UNNA FLEXIBLE Venda Cola de Zinc Cierre con tira de gasa BOTTE D'UNNA FLEXIBLE Bande Unna elastique Gaze tissee REF 100-3444 Bandage Size/Tomano/Format du pansement 3'' X 10 Yds. (7.6 cm X 9 meters) Henry Schein, Inc. HENRY SCHEIN FLEXIBLE UNNA BOOT zinc oxide dressing PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:0 40 4-0 0 0 9 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH ACACIA (UNII: 5C540 3N26 O) CASTO R O IL (UNII: D5340 Y2I9 G) GLYCERIN (UNII: PDC6 A3C0 OX) PETRO LATUM (UNII: 4T6 H12BN9 U) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:0 40 4-0 0 0 9 -0 3 1 in 1 BO Read the complete document