Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Cardinal Health 200, Inc.
TOPICAL
OTC DRUG
•first aid to help prevent skin infection in minor cuts, scrapes, and burns
OTC monograph not final
POVIDONE-IODINE PREP PAD- POVIDONE-IODINE SOLUTION CARDINAL HEALTH 200, INC. ---------- POVIDONE-IODINE PREP PAD DRUG FACTS _ACTIVE INGREDIENT_ Povidone-Iodine USP 10% (equivalent to 1% titratable iodine) _PURPOSE_ First Aid Antiseptic _USE_ •first aid to help prevent skin infection in minor cuts, scrapes, and burns _WARNINGS_ For external use only. Do not apply to persons allergic to Iodine ALLERGY ALERT: DO NOT USE • in the eyes or apply over large areas of the body • longer than one week unless directed by a doctor ASK A DOCTOR BEFORE USE IF YOU HAVE • deep or puncture wounds • animal bites • serious burns STOP USE AND CONSULT A DOCTOR if the condition persists or gets worse KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ • clean the affected area • apply a small amount of this product on the area 1-3 times daily • may be covered with a sterile bandage • if bandaged, let dry first _OTHER INFORMATION_ • store at 15°-30°C (59°-86°F) _INACTIVE INGREDIENTS_ (purified) water, glycerol, nonylphenol ethoxylate, citric acid, sodium hydroxide PACKAGE LABELING: PACKET LABELING: BOX LABELING: CARTON LABELING: POVIDONE-IODINE PREP PAD povidone-iodine solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:63517-400 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:63517- 400-83 10 in 1 CARTON 08/05/2016 1 100 in 1 BOX 1 0.56 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Cardinal Health 200, Inc. MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAP Lire le document complet