País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Sion Biotext Medical Ltd
TOPICAL
OTC DRUG
Antiseptic - Antiseptic cleanser to help prevent infection in minor cuts, scrapes and burns. - For preparation of the skin prior to surgery. - Helps reduce bacteria that can potentially cause skin infection. - In the eyes - As a first aid antiseptic for longer than 1 week - Over large areas of the body - Deep or puncture wounds - Animal bites - Serious burns - Condition worsens or persists for more than 72 hours - Irritation and redness develops
OTC monograph not final
POVIDONE IODINE- POVIDONE-IODINE SWAB SION BIOTEXT MEDICAL LTD ---------- POVIDONE IODINE PREP PAD ACTIVE INGREDIENT Povidone Iodine 10% PURPOSE Antiseptic USES Antiseptic cleanser to help prevent infection in minor cuts, scrapes and burns. For preparation of the skin prior to surgery. Helps reduce bacteria that can potentially cause skin infection. WARNINGS FOR EXTERNAL USE ONLY. DO NOT USE In the eyes As a first aid antiseptic for longer than 1 week Over large areas of the body ASK A DOCTOR BEFORE USE IF YOU HAVE Deep or puncture wounds Animal bites Serious burns STOP USE AND ASK A DOCTOR IF Condition worsens or persists for more than 72 hours Irritation and redness develops KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Tear at notch Remove applicator Use only once AS A FIRST AID ANTISPETIC Clean affected area apply 1-3 times daily May be covered with a sterile bandage If bandaged, let dry first. FOR PREOPERATIVE PATIENT SKIN PREPARATION Clean area Apply to operative site prior to surgery using applicator OTHER INFORMATION Store at room temperature Avoid excessive heat INACTIVE INGREDIENTS Nonoxynol-9, water PRINCIPAL DISPLAY PANEL 100 Medium Povidone-Iodine Prep pads Antispetic/Germicide For External Use Only Sion Biotext Medical Ltd. POVIDONE IODINE povidone-iodine swab Sion Biotext Medical Ltd PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:68786-140 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 0.1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) NONOXYNOL-9 (UNII: 48Q180SH9T) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:68786-140- 01 10 in 1 CASE 04/17/2013 1 100 in 1 BOX 1 1 in 1 PACKET; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START Leia o documento completo