Label: LIGHTS POVIDONE IODINE SOLUTION- povidone-iodine solution

  • NDC Code(s): 61333-201-01
  • Packager: Lights Medical Manufacture Co., Ltd.
  • 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 January 16, 2023

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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

    For external use only

    Do not use in eyes

    Avoid "pooling" beneath patients. Prolonged exposure to wet solution may cause skin irritation

  • 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% available iodine
    • latex free
    • for hospital or professional use only
  • INACTIVE INGREDIENT

    Inactive Ingredient

    Disodium hydrogen phosphate, citric acid, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LIGHTS POVIDONE IODINE SOLUTION 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1.18 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61333-201-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/22/2014
    Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
    Registrant - Lights Medical Manufacture Co., Ltd. (529128649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-201)
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