Label: HENRY SCHEIN FLEXIBLE UNNA BOOT WITH CALAMINE- zinc oxide, calamine dressing
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Contains inactivated NDC Code(s)
NDC Code(s): 0404-0010-03 - Packager: Henry Schein, Inc.
- 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
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Principal Display Panel
NDC 0404-0010-03
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 900-7455
Bandage Size/Tomano/Format du pansement/ BandagengroBe/Misura della fascia:
3'' X 10 Yds. (7.6 cm X 9 meters)
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INGREDIENTS AND APPEARANCE
HENRY SCHEIN FLEXIBLE UNNA BOOT WITH CALAMINE
zinc oxide, calamine dressingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25.985 g FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 0.015 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:0404-0010-03 1 in 1 BOX; Type 0: Not a Combination Product 07/27/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/27/2016 Labeler - Henry Schein, Inc. (012430880) Establishment Name Address ID/FEI Business Operations Laboratorios Le Roy 588387394 manufacture(0404-0010)