Label: LIGHTS POVINDONE IODINE SWABSTICK- povidone-iodine solution

  • NDC Code(s): 61333-204-01
  • Packager: Lights Medical Manufacture Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient: Povidone-Iodine USP (10%)

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Use:

    Health care antiseptic for prepapration of skin prior to surgery.

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

  • WARNINGS

    Warnings:

    For external use only

    Do not *use or apply to the eyes *to individuals who are allergic or sensitive to iodine, *over large area of the body, *as first aid antiseptic longer than a week unless directed by a doctor 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or consult a poison control center immediately

  • ASK DOCTOR

    Discontinue use if irritation and redness develop. Consult a doctor iin case of deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if infection occurs or if condition persists or increases

  • DOSAGE & ADMINISTRATION

    For preparation of the skin prior surgery: clean the affacted area, remove swabstick, apply to the operative site prior to surgery

    For use as first aid antiseptic: clean the affacted area, apply a small anount of the product to the area 1-3 times daily. Maybe covered with a sterile bandage. If bandaged, let dry first.

  • OTHER SAFETY INFORMATION

    Other information

    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive Ingredient

    Citric acid, purified water, Sodium phosphate dibasic

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  • INGREDIENTS AND APPEARANCE
    LIGHTS POVINDONE IODINE SWABSTICK 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-204
    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 DIHYDRATE (UNII: 94255I6E2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61333-204-014.3 g in 1 POUCH; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/01/2019
    Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
    Registrant - Lights Medical Manufacture Co., Ltd. (529128649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-204)