Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Shandong Haiyan Medical Manufacture Co., Ltd.
TOPICAL
OTC DRUG
Antiseptic for preparation of the skin.
OTC monograph final
POVIDONE-IODINE PAD- POVIDONE-IODINE SWAB SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD. _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._ ---------- 42339-003 ANTISEPTIC POVIDONE-IODINE PREP PAD 10% POVIDONE-IODINE, 1% AVAILABLE IODINE. SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD. WWW. HAIYAN-MEDICAL.COM ACTIVE INGREDIENT Povidone Iodine 10% w/w (equivalent to iodine 1%) PURPOSE Antiseptic USE Antiseptic for preparation of the skin. WARNINGS For external use only. Discontinue use if irritation and redness develop. Keep out of reach of Children. DIRECTIONS Apply locally as needed. Other Information Store at room temperature: 59°- 86°F(15 - 30℃) INACTIVE INGREDIENTS Purified Water POVIDONE-IODINE PAD povidone-iodine swab PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:42339-003 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 9.43 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE (UNII: SE337SVY37) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:42339-003- 01 10 in 1 CONTAINER 02/18/2012 1 100 in 1 BOX 1 0.6 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:42339-003- 02 100 in 1 CONTAINER 02/18/2012 2 100 in 1 BOX 2 0.6 g in 1 POUCH; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part333C 02/18/2012 LABELER - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Shandong Haiyan Medical Manufacture Co., Ltd. NAME ADDRESS ID/FEI BUSINESS OPERATIONS Shandong Haiyan Medical Manufacture Co., L Lesen Sie das vollständige Dokument