País: Estats Units
Idioma: anglès
Font: 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- POVIDONE-IODINE OINTMENT 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._ ---------- 0126 POVIDONE-IODINE OINTMENT _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. AVOID EXCESSIVE HEAT. Store at room temperature. _DIRECTIONS_ Apply locally as needed. _OTHER INFORMATION_ 1% titratable iodine Not made with natural rubber latex for hospital or professional use only _INACTIVE INGREDIENTS_ glycerin, polyethylene glycol, propylene glycol PACKAGE LABEL APLICARE POVIDONE-IODINE povidone-iodine ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:52380-0126 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:52380- 0126-2 1 g in 1 PACKET; Type 0: Not a Combination Product 05/31/2017 12/31/2025 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph not final part333A 05/31/2017 12/31/2025 Aplicare Products, LLC LABELER - Aplicare Products, LLC (081054904) REGISTRANT - Medline Llegiu el document complet