Country: United States
Language: English
Source: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Cure Medical LLC
TOPICAL
OTC DRUG
Purpose: Antiseptic Use: Antiseptic skin preparation
OTC monograph final
CURE THREE POVIDONE IODINE- POVIDONE-IODINE SWAB CURE MEDICAL LLC _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._ ---------- Active Ingredient: Povidone-Iodine USP (10%) Purpose: Antiseptic Use: Antiseptic skin preparation Warnings: Do not use if allergic to iodine in the eyes For external use only Avoid "pooling" beneath patients. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases infection occurs Apply locally as need Other information 1% titratable iodine Not made with natural rubber latex For hospital or professional use only Single use only Inactive Ingredient Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water CURE THREE POVIDONE IODINE povidone-iodine swab PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:7159 9 -0 0 1 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 0 .2 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I) GLYCERIN (UNII: PDC6 A3C0 OX) NO NO XYNO L-10 (UNII: K7O76 8 8 7AP) Cure Medical LLC PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:7159 9 -0 0 1-0 1 3 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct 0 2/0 7/20 18 2 NDC:7159 9 -0 0 1-0 2 1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct 0 2/0 7/20 18 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph final pa Read the complete document