Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Professional Disposables International, Inc.
TOPICAL
OTC DRUG
Antiseptic - A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery. Do not use - in the eyes, nose or mouth - on individuals who are allergic or sensitive to iodine - over large areas of the body - longer than one week unless directed by a doctor
OTC monograph not final
PVP IODINE PREP PAD MEDIUM AND LARGE- PROVIDONE IODINE SWAB PVP IODINE PREP SWABSTICK ONES AND THREES- PROVIDONE IODINE STICK PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. ---------- PVP-I ACTIVE INGREDIENT Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine) PURPOSE Antiseptic USES A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery. WARNINGS FOR EXTERNAL USE ONLY If swallowed, get medical help or contact a Poison Control Center. Discontinue use if irritation and redness develop. If condition persist for more than 72 hours or gets worse, consult a healthcare provider DIRECTIONS For preparation of the skin prior to surgery clean the treatment area remove swab apply to the operative site prior to surgery allow to dry OTHER INFORMATION Store at room temperature Avoid excessive heat INACTIVE INGREDIENTS Purified Water, Sodium Hydroxide DO NOT USE DO NOT USE - in the eyes, nose or mouth - on individuals who are allergic or sensitive to iodine - over large areas of the body - longer than one week unless directed by a doctor CONSULT A HEALTHCARE PROVIDER CONSULT A HEALTHCARE PROVIDER IN CASE OF - deep or puncture wounds - animal bites - serious burns KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN. PRINCIPAL DISPLAY PANEL Packet 1 swabstick Box 1 swabstick Packet 3 swabsticks Box 3 swabsticks Packet med Box med Packet large Box large PVP IODINE PREP PAD MEDIUM AND LARGE providone iodine swab PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:10819-3883 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:10819- 3883-1 100 in 1 BOX 01/01/1978 1 0.8 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:10 Baca dokumen lengkapnya