Label: LIGHTS POVINDONE IODINE SWABSTICK- povidone-iodine swab

  • NDC Code(s): 61333-212-01
  • 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 April 3, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient: Povidone-Iodine USP (10%)

    Equivalent to 1% titratable Iodine

  • 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 right away

  • 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, disodium phosphate, purified water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LIGHTS POVINDONE IODINE SWABSTICK 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-212
    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:61333-212-011 in 1 POUCH04/03/2023
    11.5 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/03/2023
    Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
    Registrant - Lights Medical Manufacture Co., Ltd. (529128649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-212)
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