Label: STRONG IODINE TINCTURE- iodine tincture liquid

  • 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 November 9, 2017

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Alcohol 85%

  • Purpose

    Antiseptic

  • Uses

    To prevent infection in mior cuts, scrapes, and burns.

  • Warnings

    For external use only

  • Ask a doctor if you have:

    deep or puncture wounds

    animal bites

    serious burns.

  • Stop use and consult a doctor if:

    The condition persists or gets worse, or if using for longer than once a week.

  • When using this product:

    Do not use in the eyes. If contact occurs, flush with large amounts of water 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 tablespoonfuls of cornstarch or flour to a pint of water. contact a Poison Control Center immediately.

  • Directions

    Clean affacted area

    Apply a small amount on the area 1 to 3 times daily.

    May be covered with sterile bandage.

    If bandaged, let it dry first.

  • Inactive Ingredient

    Iodine 7%, Potassium Iodide 5%, Purified water

  • Label

    label

  • INGREDIENTS AND APPEARANCE
    STRONG IODINE TINCTURE 
    iodine tincture liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL850 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    IODINE (UNII: 9679TC07X4)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-1220-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/09/2017
    2NDC:0395-1220-9130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/09/2017
    Labeler - Humo Holding Group, Inc. (825672884)
    Registrant - Humo Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-1220) , label(0395-1220) , analysis(0395-1220) , pack(0395-1220)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!