A2506-18 SINGLE SHOT EPIDURAL 18G TUOHY- regional anesthesia kit   
Smiths Medical ASD, Inc.

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Drug Facts

APLICARE POVIDONE IODINE SOLUTION (povidone-iodine) solution
[Aplicare, Inc.]

3/4 FLUID OUNCE

POVIDONE-IODINE

SOLUTION

0.75 Fl. oz. (22.5)

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)

Povidone Iodine Solution

Package Label Display Panel

A2506-18

A2506-18 SINGLE SHOT EPIDURAL 18G TUOHY 
regional anesthesia kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-8368
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-8368-210 in 1 CASE
11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 22.5 mL
Part 1 of 1
APLICARE POVIDONE-IODINE  
povidone-iodine solution
Product Information
Item Code (Source)NDC:52380-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC 
SODIUM HYDROXIDE 
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0001-322.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/1984
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK96501712/14/200508/07/2014
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.107255002manufacture

Revised: 9/2014
Document Id: 4b638f2f-c831-4d60-b81b-7099885641d8
Set id: ab932fc9-9f48-4524-8899-d8a676ef88f5
Version: 4
Effective Time: 20140910
 
Smiths Medical ASD, Inc.