4039-1 PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN- tubes, vials, systems, serum separators, blood collection   
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 wounds

- puncture wounds

- serious burns

Stop use and ask a doctor if

- infection occurs

- 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.

Apply locally as needed.

  • 1% titratable iodine
  • Latex free
  • For hospital or professional use only

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

APLICARE

POVIDONE-IODINE PREP PAD

ANTISEPTIC

STERILE SOLUTION

Povidone-Iodine Prep Pad.jpg

Package Label Display Panel

4039-1

4039-1 PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN 
tubes, vials, systems, serum separators, blood collection kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-5147
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-5147-6100 in 1 CASE
11 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 0.5 mL
Part 1 of 1
APLICARE POVIDONE-IODINE PREP PAD 
povidone-iodine solution
Product Information
Item Code (Source)NDC:52380-4111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-4111-10.5 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK84098612/14/200511/22/2019
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.081054904manufacture

Revised: 11/2019
 
Smiths Medical ASD, Inc.