Label: ALPHA ONE- povidone-iodine gel

  • Category: HUMAN OTC DRUG LABEL

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 October 23, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients:
    Povidone-iodine USP 10% w/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • Health care antiseptic for preparation of the skin prior to surgery
    • First aid antiseptic to help reducce bacteria that potentially can cause skin infection
    • For hospital and professional use

  • WARNINGS

    Warnings For external use only.

    Do not use:

    • in the eyes.
    • on individuals who are allergic or sensitive to iodine
    • as a first aid antiseptic longer than 1 week unless directed by a doctor.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns.
  • STOP USE

    Stop use and ask a doctor if

    • irritation or redness develop
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    For preparation of the skin prior to surgery

    • apply to the operative site prior to surgery

    As a first aid antiseptic

    • clean the affected area
    • apply a small amount of this product to the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Disodium hydrogen phosphate, Glycerin, Hydroxyethyl cellulose, Purified water

  • OTHER SAFETY INFORMATION

    Other Information

    Store at room temperature.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    ALPHA ONE 
    povidone-iodine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53152-2004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53152-2004-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/24/2019
    Labeler - AOSS Medical Supply, Inc. (787524651)
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