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 Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-9481
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NHRIC:51688-9481-2 10 in 1 CASE
1 1 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 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 Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iodine povacrylex (UNII: 6E43AWY083) (Iodine - UNII:9679TC07X4) Iodine povacrylex 6.02 mg  in 1 mL
Isopropyl alcohol (UNII: ND2M416302) (Isopropyl alcohol - UNII:ND2M416302) Isopropyl alcohol 636.4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:17518-011-09 6 mL in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021586 09/29/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K965017 10/14/2006
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
Name Address ID/FEI Business Operations
Smiths Medical ASD, Inc. 137835299 relabel, manufacture
Establishment
Name Address ID/FEI Business Operations
3M Company 054236443 manufacture

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.