Label: EL VALLE DECOLORIZED IODINE- alcohol tincture

  • NDC Code(s): 55758-374-01, 55758-374-02
  • Packager: Pharmadel LLC
  • 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 June 14, 2023

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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 not finalpart333A05/31/2023
    Labeler - Pharmadel LLC (030129680)
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