Label: APOTHECARY PVP TOPICAL- povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 12, 2016

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  • Active ingredient

    Povidone-Iodine, 10% (equivalent to 1% available iodine)

  • Purpose

    Antiseptic

  • Uses

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

  • Warnings

    For external use only.

    Do not use

    • in the eyes
    • longer than one week unless directed by a doctor
    • on individuals who are allergic or sensitive to iodine
    • or apply over large areas of the body

    Stop use and ask a doctor

    • if irritation and redness develop
    • if condition persists for more than 72 hours
    • in case of deep or puncture wounds, animal bites or serious burns.

    Keep out of reach of children.

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

  • Directions

    • Clean the affected area.
    • Apply a small amount of this product on the area 1 to 3 times daily
    • May be covered with a sterile bandage. If bandaged, let dry first.
  • Other Information

    Protect from freezing. Avoid excessive heat.

  • Inactive ingredients

    Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.

  • Package/Label Principal Display Panel

    Walgreens Povidone Iodine solution label

    Walgreens

    Apothecary

    Povidone Iodine

    10% Topical Solution

    Topical antiseptic germicide

    Helps prevent infection

    • burns
    • cuts
    • minor skin wounds
    • scrapes

    FOR EXTERNAL USE ONLY

    8 FL OZ (236 mL)

  • INGREDIENTS AND APPEARANCE
    APOTHECARY PVP TOPICAL 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0939
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0939-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/13/2011
    Labeler - Walgreen Company (008965063)
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