מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Acme United Corporation
TOPICAL
OTC DRUG
Purpose Antiseptic Use Antispetic for preparation of the skin.
OTC monograph not final
FIRST AID ONLY POVIDONE-IODINE PREP PAD- POVIDONE-IODINE PATCH ACME UNITED CORPORATION _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._ ---------- FIRST AID ONLY POVIDONE-IODINE PREP PAD ACTIVE INGREDIENTS ACTIVE INGREDIENTS Povidone Iodine 10% PURPOS E PURPOSE Antiseptic US E USE Antispetic for preparation of the skin. WARNINGS WARNINGS •For external use only. •Discontinue use if irritation and redness develop. •Keep out of reach of children. KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or contact a Poison Control Center right away. DIRECTIONS DIRECTIONS Apply locally as needed. OTHER INFORMATION OTHER INFORMATION Store at room temperature 15° - 30°C (59° - 86°F) INACTIVE INGREDIENT INACTIVE INGREDIENT purified water PACKAGE PRINCIPAL DISPLAY PANEL FIRST AID ONLY POVIDONE-IODINE PREP PAD povidone-iodine patch Acme United Corporation PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:0 9 24-8 110 (NDC:440 19 -8 11) ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4) IODINE 10 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:0 9 24- 8 110 -0 0 1 in 1 POUCH 0 7/26 /20 17 1 0 .45 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt333A 0 7/24/20 17 LABELER - Acme United Corporation (001180207) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Acme United Co rpo ratio n 0 459 24339 relabel(0 9 24-8 110 ) , repack(0 9 24-8 110 ) ESTAB קרא את המסמך השלם