Label: LIGHTS POVIDONE IODINE PREP PAD- povidone-iodine solution

  • NDC Code(s): 61333-203-01
  • 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 March 27, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient: Povidone-Iodine USP (10%)

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Use:

    First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

  • WARNINGS

    Warnings:

    For external use only

    Do not use if allergic to iodine or in the eyes

  • 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 wounds, puncture wounds or serious burns

    Stop use and ask a doctor if infection occurs or if redness, irritation, swelling, or pain persists or increases

  • 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

    Citric acid, purified water, Sodium phosphate dibasic

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LIGHTS POVIDONE IODINE PREP PAD 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 g
    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:61333-203-010.67 g in 1 POUCH; Type 0: Not a Combination Product10/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/15/2015
    Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
    Registrant - Lights Medical Manufacture Co., Ltd. (529128649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-203)
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