Label: FIRST AID ONLY POVIDONE-IODINE PREP PAD- povidone-iodine patch

  • 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 July 24, 2017

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  • Active Ingredients

    Active Ingredients Povidone Iodine 10%

  • Purpose

    Purpose Antiseptic

  • Use

    Use Antispetic for preparation of the skin.

  • Warnings

    Warnings •For external use only.

    •Discontinue use if irritation and redness develop.

    •Keep out of reach of children.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Directions Apply locally as needed.

  • Other Information

    Other Information Store at room temperature 15° - 30°C (59° - 86°F)

  • Inactive Ingredient

    Inactive Ingredient purified water

  • Package Principal Display Panel

    Label Image

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY POVIDONE-IODINE PREP PAD 
    povidone-iodine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-8110(NDC:44019-811)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-8110-001 in 1 POUCH07/26/2017
    10.45 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/24/2017
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-8110) , repack(0924-8110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-8110) , repack(0924-8110)