Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Changzhou Maokang Medical Products Co., Ltd
TOPICAL
OTC DRUG
for antiseptic skin preparation
OTC monograph not final
POVIDONE IODINE SWABSTICKS- POVIDONE-IODINE SOLUTION CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD ---------- POVIDONE IODINE SWABSTICKS _DRUG FACTS_ _ACTIVE INGREDIENT_ Povidone-lodine USP10% _PURPOSE_ Antiseptic _USE_ for antiseptic skin preparation _WARNINGS_ For external use only. DO NOT USE if allergic to lodine do not use in the eyes _STOP USE AND ASK A DOCTOR IF_ redness,irritation,swelling or pain persists or increases infection occurs _KEEP OUT OF REACH OF CHILDREN._ In case of accidental ingestion,seek professional assistance or consult a poison control center immediately. _Avoid pooling beneath patient._ ASK A DOCTOR BEFORE USE _if injuries are _ deep or puncture wounds serious burns _DIRECTIONS_ apply locally as needed _OTHER INFORMATION_ ■1% titratable iodine ■For hospital or professional use only ■Store at room temperature. ■Avoid excessive heat. ■Not made with natural rubber latex. _INACTIVE INGREDIENTS:_ Citric Acid,Alkyl Glucoside,Hydroxyethyl Cellulose,Nonoxynol- 10,Glycerin,Sodium Hydroxide,Potassium lodide,Purified Water. PACKAGE LABELING: POVIDONE IODINE SWABSTICKS povidone-iodine solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:59050-270 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 100 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH Changzhou Maokang Medical Products Co., Ltd HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) NONOXYNOL-10 (UNII: K7O76887AP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) POTASSIUM IODIDE (UNII: 1C4QK22F9J) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:59050-270- 00 6 g in 1 POUCH; Type 0: Not a Combination Product 09/05/2023 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug 505G(a)(3) 09/05/2023 LABELER - Cha Preberite celoten dokument