Label: FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES- povidone-iodine 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 January 15, 2014

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  • FIRSTLINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules

  • Active ingredient

    Povidone-iodine 10%

  • Purpose

    Antiseptic

  • Uses

    • Patient preoperative skin preparation
    • For preparation of the skin prior to surgery
    • Helps to reduce bacteria that potentially can cause skin infection
  • Warnings

    For external use only.

    Do not use

    • in the eyes

    When using this product

    keep out of eyes, ears, and mouth

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours
    • infection occurs

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • clean the area
    • reverse cardboard sleeve then crush at dot between thumb and forefinger
    • allow solution to saturate tip
    • apply product to the operative site prior to surgery using the applicator tip
  • Other information

    • Store at room temperature away from light
    • Keep from freezing or excessive heat
  • Inactive ingredients

    • citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
  • Questions?

    call 1-866-433-2131 Monday through Friday 9:00am-5:00pm est

  • LINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules 25 count (41477-420-69)

    • Representative Package Labeling
    OuterLabel

    InnerLabel

    FlyerLabel

  • INGREDIENTS AND APPEARANCE
    FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES  
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41477-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41477-420-6925 in 1 PACKAGE
    15 mL in 1 AMPULE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/15/2014
    Labeler - The Wild Side, Llc dba Firstline Medical (969962864)
    Registrant - The Wild Side, Llc dba Firstline Medical (969962864)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander Corporation040756421manufacture(41477-420)
    Establishment
    NameAddressID/FEIBusiness Operations
    STERIS Isomedix933290723manufacture(41477-420)
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