Label: HEALTH MART IODIDES- alcohol liquid

  • NDC Code(s): 62011-0116-1
  • Packager: Strategic Sourcing Services LLC
  • 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 March 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Health Mart Iodides Tincture

    Drug Facts

  • Active Ingredient

    Alcohol 48% v/v

  • Purpose

    Antiseptic

  • Uses

    To help prevent infection in in minor: cuts, scrapes and burns.

  • Warnings

    For external use only

    Ask a doctor before use if you have 

    deep or puncture wounds. Animal bites. Serious burns.

    Stop use and consult a doctor if:

    Condition persists or gets worse, or if using this product for more than 1 week.

    When using this product.

    Do not use in the eyes. If contact occurs, flush with large amounts of water while lifting upper and lower lids. Do not apply over large areas of the body.

    Keep out of reach of children.

    • In case of accidental ingestion, give milk, then a starch solution made by mixing two tablespoons of cornstarch or flour to a pint of water, Contact a Poison Control Center immediately.
  • Directions

    • Clean the affected area. Apply a small amount to the affected area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
  • Inactive Ingredient

    Ammonia, iodine, potassium iodide, purified water.

  • Other information

    Will stain skin and clothing

  • Flammable

    Keep away from spark, heat and flame

  • Label

    HMDecolorized.jpgNew Label

  • INGREDIENTS AND APPEARANCE
    HEALTH MART IODIDES 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.48 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    IODINE (UNII: 9679TC07X4)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0116-159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2008
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(62011-0116) , analysis(62011-0116) , pack(62011-0116) , label(62011-0116)
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