A2528 NERVE BLOCK- anesthesia conduction kit   
Smiths Medical ASD, Inc.

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Drug Facts

Povidone-iodine

Antiseptic

Antiseptic skin preparation

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

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Apply locally as needed.

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

APLICARE

POVIDONE-IODINE SOLUTION

ANTISEPTIC

STERILE Solution

Povidone Iodine Solution

Package Label Display Panel

A2528

A2528 NERVE BLOCK 
anesthesia conduction kit kit
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-5050
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NHRIC:51688-5050-2 10 in 1 CASE
1 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product
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 solution
Product 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; Type 0: Not a Combination Product
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
premarket notification K965017 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

Revised: 5/2016
Document Id: c47aa7d1-ad88-4b31-aced-3fcbd018af2c
Set id: 557fd005-29ae-497f-ab03-4aa9c050cb50
Version: 2
Effective Time: 20160519
 
Smiths Medical ASD, Inc.