Label: POVIDONE-IODINE PREP PAD- povidone-iodine swab

  • NDC Code(s): 71584-0104-1
  • Packager: Guangdong Comfort Medical Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2022

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  • Active ingredient

    Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

  • Purpose

    Antiseptic

  • CAUTION: Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away.

  • Indications and usage section

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

  • WARNINGS

    For external use only. Flammable, keep away from fire or flame.

    Do notuse

    ﹒in the eyes or apply over large areas of the body.

    ﹒on individuals who are allergic or sensitive to iodine.

    Stop use

    If irritation, redness or other symptoms develop.

    Ask a doctor

    If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

  • Directions

    Apply product on the area 1-3 times daily and discard.

  • INACTIVE INGREDIENT

    ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

  • DRUG FACTS

    Active ingredient

    Povidone Iodine USP, 10% w/v

    (equivalent to 1% titratable iodine)

    Purpose

    Antiseptic

    Use

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

    Warnings

    For external use only. Flammable, keep away from fire or flame.

    Do notuse

    ﹒in the eyes or apply over large areas of the body.

    ﹒on individuals who are allergic or sensitive to iodine.

    Stop use

    If irritation, redness or other symptoms develop.

    Ask a doctor

    If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

    CAUTION: Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

    Directions

    Apply product on the area 1-3 times daily and discard.

    Other information: Store at room temperature.

    Inactive ingredients

    ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

    image of carton

    image of packet

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PREP PAD 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71584-0104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE9.43 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71584-0104-19.43 g in 1 POUCH; Type 0: Not a Combination Product07/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00307/17/2017
    Labeler - Guangdong Comfort Medical Products Co., Ltd. (544507534)
    Registrant - Guangdong Comfort Medical Products Co., Ltd. (544507534)