Label: FULL CARE POVIDONE IODINE PREP PAD- povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 8, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient: Povidone-Iodine USP (10%)

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Use: Antiseptic skin preparation

  • WARNINGS

    Warnings:

    Do not use

    • if allergic to iodine
    • in the eyes

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • ASK DOCTOR

    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • redness, irritation, swelling, or pain persists or increases
    • infection occurs
  • DOSAGE & ADMINISTRATION

    Apply locally as need

  • OTHER SAFETY INFORMATION

    Other information

    • For hospital or professional use only
  • INACTIVE INGREDIENT

    Inactive Ingredient

    Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Purified Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FULL CARE POVIDONE IODINE PREP PAD 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65028-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65028-007-010.2 mL in 1 POUCH
    2NDC:65028-007-020.4 mL in 1 POUCH
    3NDC:65028-007-030.8 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/17/2014
    Labeler - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shaoxing Fuqing Health Products Co., Ltd.530545003manufacture(65028-007)
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