País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Trifecta Pharmaceuticals USA LLC
TOPICAL
OTC DRUG
First Aid Antiseptic First Aid to help prevent infection in minor cuts, scrapes and burns. - deep or puncture wounds - animal bites - serious burns - The condition persists or gets worse - you need to use this product for more than 1 week
OTC monograph not final
POVIDONE IODINE- POVIDONE IODINE 10% OINTMENT TRIFECTA PHARMACEUTICALS USA 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._ ---------- GLOBE POVIDONE IODINE USP 10% ACTIVE INGREDIENT Povidone Iodine USP 10% w/w (available iodine 1%) PURPOSE First Aid Antiseptic USES First Aid to help prevent infection in minor cuts, scrapes and burns. WARNINGS For external Use Only Do not use in eyes over large areas of the body if you are allergic to any of the ingredients DIRECTIONS Clean the affected area apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily. may be covered with a sterile bandage ASK DOCTOR BEFORE USE IF YOU HAVE deep or puncture wounds animal bites serious burns INACTIVE INGREDIENTS Polyethylene glycol 400, Polyethylene glycol 4000 QUESTIONS? Call 1-888-296-9067 STOP USE AND ASK A DOCTOR IF The condition persists or gets worse you need to use this product for more than 1 week STORAGE INFORMATION Store at controlled room temperature 20º to 25ºC (68ºF to 77ºF). close cap tightly after use. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center immediately (1-800- 222-1222) right away. QUESTIONS 1-888-296-9067 OTHER INFORMATION Distributed By: Trifecta Pharmaceuticals USA® 101 NE Third Ave. Ste 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com POVIDONE IODINE povidone iodine 10% ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:69396-112 ROUTE OF ADMINISTRATION TOPICAL Trifecta Pharmaceuticals USA LLC 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 POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PACKAGING # ITEM CODE PA Leia o documento completo