Label: ANTISEPTIC- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 10, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Isopropyl Alcohol 71.5%

  • Purpose

    Antiseptic

  • Uses

    For preparation of the skin prior to injection or venipuncture

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not use with electrocautery procedures or in or near the eyes. For external use only.

    Stop use and ask a doctor if irritation or redness develop and persists for more than 72 hours

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

  • Directions

    • clean the area
    • start at the venipuncture site and apply in a circular fashion using friction
  • Inactive ingredients

    purified/deionized water, ethyl ester of PVMA/MA copolymer, ethyl alcohol SDA-40B, acetyl tributyl citrate, chloroxylenol

  • PRINCIPAL DISPLAY PANEL – packet label

    REORDER NO. ZA50075

    LATEX FREE

    NDC 52641-700-02

    ReliaMed

    I.V.
    Antiseptic Wipes

    For preparation of the skin prior
    to injection or venipuncture

    Contains: One Wipe

    Distributed by ReliaMed

    Ft. Worth, TX 76106 1-800-409-2848

    Made in the U.S.A. Rev 050611

    TEAR HERE

    PRINCIPAL DISPLAY PANEL – packet label
  • PRINCIPAL DISPLAY PANEL – box label

    NEW

    ReliaMed

    REORDER NO. ZA50075

    LATEX FREE

    NDC 52641-700-02

    I.V. Antiseptic Wipes

    For preparation of the skin prior to injection or venipuncture

    75 Individual Wipes

    • Protect skin from adhesives
    • Non-irritating to intact skin
    • Thick, soft application pad
      PRINCIPAL DISPLAY PANEL – box label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52641-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302) isopropyl alcohol0.56118 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    acetyltributyl citrate (UNII: 0ZBX0N59RZ)  
    chloroxylenol (UNII: 0F32U78V2Q)  
    ethyl nitrate (UNII: E1ZT886LR5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52641-700-0275 in 1 BOX06/23/2011
    11.2 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:52641-700-0150 in 1 BOX06/23/2011
    21.2 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 finalpart333A06/23/2011
    Labeler - ReliaMed (049386139)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(52641-700)
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