Label: HALODINE ORAL ANTISEPTIC- povidone-iodine spray

  • 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 October 14, 2020

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  • Drug Facts

  • Active Ingredient

    Povidone-Iodine USP, 1.25%

    (0.125% Available Iodine)

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses • Oral Antiseptic • First aid to help prevent infection in minor oral irritation caused by dental procedures

  • Warnings For external use only.

    Do not use • If allergic to iodine • In the eyes • On children less than 3 years old • For more than 7 days unless directed by a dentist or doctor Stop use and promptly ask your dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

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

  • DOSAGE & ADMINISTRATION

    Directions For oral antisepsis in adults and children 3 years of age and older:
    1. Press down pump completely and spray twice into mouth. 2. Swish vigorously in mouth for 15 seconds. 3. Slightly lift chin and tilt head back to gargle. Spit out excess. Children under 3 years of age: Consult a dentist or doctor

  • STORAGE AND HANDLING

    Other Information • Not made with natural rubber latex • Store at room temperature; avoid excessive heat

  • INACTIVE INGREDIENT

    Inactive Ingredients hydroxyethylcellulose, purified water

  • QUESTIONS

    Questions or comments? contact@halodine.com

  • SPL UNCLASSIFIED SECTION

    Povidone-Iodine USP, 1.25%

    Helps Reduce Risk of Infection

    4-Hour Formula

    halodine.com

    PATENT PENDING

    Manufactured in the U.S.A.

    for Halodine LLC 111 NE 1st St,

    Ste 806, Miami, FL 33132

  • Packaging

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    HALODINE ORAL ANTISEPTIC 
    povidone-iodine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78371-401
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78371-401-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/01/2020
    Labeler - Halodine Llc (117526113)
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