![A1052-22 AMNIOCENTESIS 22G QUINCKE () KIT [SMITHS MEDICAL ASD, INC.]](https://medic.hrt.org//dailymed/images/d9f0d3ba-1785-4613-9fc3-359d917b1ada/A1052-22.jpg)
![A1052-22 AMNIOCENTESIS 22G QUINCKE () KIT [SMITHS MEDICAL ASD, INC.]](https://medic.hrt.org//dailymed/images/d9f0d3ba-1785-4613-9fc3-359d917b1ada/Povidone Iodine Solution.jpg)
-
PRINCIPAL DISPLAY PANEL
APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution
[Aplicare, Inc.]3/4 Ounce Povidone Iodine Packet
Active Ingredient
Povidone-iodine
Purpose
Antiseptic
Use
Antispetic skin preparation
Warnings
Do not use
-if allergic to iodine.
-in the eyes
For external use only.
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
Keep out of reach of children
In case of accidental ingestion, seek professional help or consult a poison control center immediately.
Directions
Apply locally as needed.
Inactive Ingredients
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
Questions or comments?
1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
A1052-22 AMNIOCENTESIS 22G QUINCKE
sampler, amniotic fluid (amniocentesis tray) kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-1236 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:51688-1236-2 10 in 1 CASE 1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 22.5 mL Part 1 of 1 APLICARE POVIDONE-IODINE
povidone-iodine solutionProduct Information Item Code (Source) NDC:52380-0001 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 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM HYDROXIDE (UNII: 55X04QC32I) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52380-0001-3 22.5 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/01/1984 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date exempt device HIO 12/14/2005 Labeler - Smiths Medical ASD, Inc. (137835299) Establishment Name Address ID/FEI Business Operations Smiths Medical ASD, Inc. 137835299 manufacture Establishment Name Address ID/FEI Business Operations Aplicare, Inc. 107255002 manufacture
