I.V. PREP ANTISEPTIC WIPE- isopropyl alcohol solution 
Smith & Nephew, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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I.V. Prep Antiseptic Wipe

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH PACKET)

Isopropyl Alcohol 70% V/V

PURPOSE

Antiseptic

USES

Preparation of skin prior to injection or venipuncture

WARNINGS

  • For external use only
  • Flammable. Keep away from fire or flame

  • Do not use
    • with electrocautery procedures
    • in or near the eyes

  • Discontinue use if irritation or redness develops
  • If condition persists more than 72 hours, contact a doctor

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

DIRECTIONS

  • clean the area
  • start at the venipuncture site and apply in a circular fashion using friction
  • dry and repeat procedure

INACTIVE INGREDIENTS

acetyl tributyl citrate, butyl ester of PVM/MA copolymer, triclosan, water

QUESTION OR COMMENTS?

Smith & Nephew, Inc

Largo, FL 33773

Customer Care Center:

1 800 876-1261

www.smith-nephew.com


PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- BOX OF 50 WIPES (Front)

#59421200

NDC 50484-212-00

I.V. PREP

Antiseptic Wipes

  • for preparation of the skin prior to injection or venipuncture
  • contains 70% IPA

50 Wipes

Package Display - Box (Front)

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- BOX OF 50 WIPES (Back)

#59421200

NDC 50484-212-00

I.V. PREP

Antiseptic Wipes

Package Display - Box (Back)

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- 1 Packet

#59421200

NDC 50484-212-00

I.V. PREP

Antiseptic Wipes

  • for preparation of the skin prior to injection or venipuncture
  • contains 70% IPA

1 Wipe

Package Display - Packet



I.V. PREP ANTISEPTIC WIPE 
isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.57 
Inactive Ingredients
Ingredient NameStrength
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
WATER (UNII: 059QF0KO0R)  
TRICLOSAN (UNII: 4NM5039Y5X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50484-212-0050 in 1 BOX10/01/199906/30/2018
1NDC:50484-212-011 in 1.0 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/199906/30/2018
Labeler - Smith & Nephew, Inc. (827731451)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC dba Multi-Pack Solutions557434805MANUFACTURE(50484-212)

Revised: 7/2016
Document Id: 34991422-e43d-4ed5-bed6-b1ae9f470005
Set id: 9d8edc88-05a4-4efb-bcd0-ca5590f5e77d
Version: 11
Effective Time: 20160722
 
Smith & Nephew, Inc.