3097-20 CONTINUOUS EPIDURAL 18G HUSTEAD by Smiths Medical ASD, Inc. / Aplicare, Inc.

3097-20 CONTINUOUS EPIDURAL 18G HUSTEAD by

Drug Labeling and Warnings

3097-20 CONTINUOUS EPIDURAL 18G HUSTEAD by is a Other medication manufactured, distributed, or labeled by Smiths Medical ASD, Inc., Aplicare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

3097-20 CONTINUOUS EPIDURAL 18G HUSTEAD- 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.

  • 1% titratable iodine
  • latex free
  • for hospital or professional use only

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

3097-20

3097-20 CONTINUOUS EPIDURAL 18G HUSTEAD 
anesthesia conduction kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-8438
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-8438-210 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 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: 52380-0001-322.5 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 finalpart333A03/01/1984
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK96501712/14/200504/15/2020
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.081054904manufacture

Revised: 4/2020
 
Smiths Medical ASD, Inc.