Label: CURE THREE POVIDONE IODINE- povidone-iodine swab

  • 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 February 7, 2018

If you are a consumer or patient please visit this version.

  • 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

    Avoid "pooling" beneath patients.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

  • 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

    • 1% titratable iodine
    • Not made with natural rubber latex
    • For hospital or professional use only
    • Single use only
  • INACTIVE INGREDIENT

    Inactive Ingredient

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CURE THREE POVIDONE IODINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71599-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.2 g
    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:71599-001-013 in 1 POUCH; Type 0: Not a Combination Product02/07/2018
    2NDC:71599-001-021 in 1 POUCH; Type 0: Not a Combination Product02/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/07/2018
    Labeler - Cure Medical LLC (070643426)
    Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shaoxing Fuqing Health Products Co., Ltd.530545003manufacture(71599-001)