Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Aplicare Products, LLC
TOPICAL
OTC DRUG
Antiseptic antiseptic skin preparation
OTC monograph not final
APLICARE POVIDONE-IODINE PREP PAD- POVIDONE-IODINE SOLUTION APLICARE PRODUCTS, 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._ ---------- 4111 APLICARE POVIDONE-IODINE PREP PAD _ACTIVE INGREDIENT_ Povidone-iodine USP 10% _PURPOSE_ Antiseptic _USE_ antiseptic skin preparation _WARNINGS_ FOR EXTERNAL USE ONLY DO NOT USE if allergic to iodine or in the eyes ASK A DOCTOR BEFORE USE if injuries are deep wounds, puncture wounds, or serious burns STOP USE AND ASK A DOCTOR if infection occurs or if redness, irritation, swelling or pain persists or increases KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately. _DIRECTIONS_ apply locally as needed _OTHER INFORMATION_ Prep pad size: 1-1/4" × 1-1/2" 1% titratable iodine not made with natural rubber latex for hospital or professional use only avoid excessive heat - store at room temperature _INACTIVE INGREDIENTS_ citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water MANUFACTURING INFORMATION Manufactured by: Aplicare Products, LLC 550 Research Pkwy, Meriden CT 06450 USA Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA with domestic and foreign materials 1-800-633-5463 RF18APL REF: APLP1111 PACKAGE LABEL APLICARE POVIDONE-IODINE PREP PAD povidone-iodine solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:52380-4111 ROUTE OF ADMINISTRATION TOPICAL Aplicare Products, LLC ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) NONOXYNOL-9 (UNII: 48Q180SH9T) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 29 Baca dokumen lengkapnya