Label: EL VALLE DECOLORIZED IODINE- alcohol tincture

  • NDC Code(s): 55758-374-01, 55758-374-02
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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  • Drug Facts

    Drug facts

  • Active Ingredient & Purpose

    Gentian Violet 1%

    Active ingredientPurpose
    Alcohol 48% .............................First aid antiseptic

  • Uses

    First aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    FOR EXTERNAL USE ONLY.

    Do not use

    • longer than 1 week, unless directed by a doctor
    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • a deep or puncture wounds
    • serious burns
    • animal bites

    Stop use and consult a doctor if

    • conditions persist or gets worse

    Keep out of reach of children.

    If swallowed, get medical help, or contact a Poison Control Center immediately.

  • Directions

    • clean the affected area
    • apply a small amount directly to the affected area 1 to 3 times a day
    • may cover area with sterile bandage
  • Other information

    • do not use if clear seal over cap is missing or broken
  • Inactive ingredients

    ammonia, iodine, sodium iodide, water

  • Prinicpal Display Panel

    PDP D IODINE

  • INGREDIENTS AND APPEARANCE
    EL VALLE DECOLORIZED IODINE 
    alcohol tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-374
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.48 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM IODIDE (UNII: F5WR8N145C)  
    IODINE (UNII: 9679TC07X4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-374-0115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/202305/31/2023
    2NDC:55758-374-0230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00405/31/2023
    Labeler - Pharmadel LLC (030129680)
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