6801 PORTEX CENTRAL LINE DRESSING- anesthesia conduction kit   
Smiths Medical ASD, Inc.

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6801 - Portex Central Line Dressing

Povidone-iodine

Ask a doctor before use if injuries are

• deep wounds

• puncture wounds

• serious burns

Stop use and ask a doctor if infection occurs or if redness,irritation, swelling or pain persists or increases.

Antiseptic

Directions

Apply locally as needed.

Do not use

• if allergic to iodine

• in the eyes

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

For external use only

Avoid excessive heat. Store at room temperature.

Other information

• titratable iodine

• latex free

• for hospital of professsional use only

Antiseptic

Inactive Ingredients

• polyethylene glycol 1450

• glycerin

• propylene glycol

DR022 - Display Panel

APLICARE

POVIDONE-IODINE OINTMENT

ANTISEPTIC

STERILE SOLUTION

Product Information

DR022 Table 1DR022 Table 2

DR022 Table 2

DR022 Table 2

Drug Facts

Povidone-iodine USP 10%

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

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
  • not made with natural rubber latex
  • for hospital or professional use only
  • for single use only

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

For questions, comments, or to report serious side effects:
800-760-3236
Monday-Friday 8:30 a.m.-5:00 p.m. EST

PRINCIPAL DISPLAY PANEL - 3 SWABSTICK PACKET

NDC 52380-5101-3

NPN 02076101

APLICARE

◀ Tear Here Hold Upright Tear Here ▶

THREE
POVIDONE-IODINE
SWABSTICKS

ANTISEPTIC
Non-Sterile Solution

Three 4-inch Saturated Swabsticks

Reorder No. S-3111

DR035 Ingredients Image

DR035 Ingredients Image

Product Information 

DR035 Table 1

DR035 Table 2

DR035 Table 2

6801 Label6801 Label

6801 PORTEX CENTRAL LINE DRESSING 
anesthesia conduction kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-0003
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-0003-420 in 1 CASE
11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 1 g
Part 21 PACKET 6.5 mL
Part 1 of 2
APLICARE POVIDONE-IODINE 
povidone-iodine ointment
Product Information
Item Code (Source)NDC:52380-0026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/1984
Part 2 of 2
APLICARE POVIDONE-IODINE TRIPLES 
povidone-iodine solution
Product Information
Item Code (Source)NDC:52380-5101
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
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.5 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 notificationK96501701/30/200711/01/2019
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture

Revised: 11/2019
Document Id: ea3e6c08-304d-4e21-ab02-ed594b0614c7
Set id: d4ef79ba-390d-452b-aa95-60b32e53bec7
Version: 2
Effective Time: 20191101
 
Smiths Medical ASD, Inc.