A3441-22 SPINAL 22G QUINCKE - regional anesthesia kit   
Smiths Medical ASD, Inc.

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Drug Facts

3M DURAPREP SURGICAL (iodine povacrylex and isopropyl alcohol) solution
[3M Health Care]

Drug Facts

Active ingredients

Iodine povacrylex (0.7% available iodine)

Isopropyl alcohol, 74% w/w

Purpose

Antiseptic

Antiseptic

Uses

patient preoperative skin preparation:

Warnings

For external use only. Flammable, keep away from fire or flame.

To reduce the risk of fire, PREP CAREFULLY:

flame figure 1

Do not use When using this product

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. On rare occasions, use of this product has been associated with skin blistering.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions (follow all directions for use)

Getting Patient Ready for Solution: Activating the Applicator: When Applying Solution:
pooling figure 1

After Applying Solution: While Waiting for Solution to Completely Dry:

Do not blot because it may remove solution from skin.

cautery figure 1


Other information

Inactive ingredients

ethyl alcohol, water

Questions?

call 1-800-228-3957 (Monday to Friday 7AM – 6PM CST). www.3M.com.

Package Label Display Panel

Surgical Solution 1

Package Label Display Panel

A3441-22

A3441-22 SPINAL 22G QUINCKE 
regional anesthesia kit c47916
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-9481
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-9481-210 in 1 CASE
11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 APPLICATOR 6 mL
Part 1 of 1
3M DURAPREP SURGICAL 
iodine povacrylex and isopropyl alcohol solution
Product Information
Item Code (Source)NDC:17518-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Iodine povacrylex (Iodine) Iodine povacrylex6.02 mg  in 1 mL
Isopropyl alcohol (Isopropyl alcohol) Isopropyl alcohol636.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17518-011-096 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02158609/29/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK96501710/14/2006
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299relabel, manufacture
Establishment
NameAddressID/FEIBusiness Operations
3M Company054236443manufacture

Revised: 10/2012
Document Id: 700c6c53-6b10-48be-8f88-2824e2373d0d
Set id: a891657b-804a-4ec1-b09a-f6d143f2c3c3
Version: 1
Effective Time: 20121010
 
Smiths Medical ASD, Inc.