Label: EL VALLE GENTIAN VIOLET- gentian violet 1% liquid

  • NDC Code(s): 55758-373-01, 55758-373-02
  • Packager: Pharmadel 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 June 20, 2023

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  • Drug Facts

    Drug facts

  • Active Ingredient & Purpose

    Gentian Violet 1%

    Active ingredientPurpose
    Gentian Violet 1% .............................First aid antespetic

  • 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

    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

    • product will stain clothing and skin
    • do not use if clear seal over cap is missing or broken
  • Inactive ingredients

    alcohol, water

  • Principal Display Panel

    EVGV PDP

  • INGREDIENTS AND APPEARANCE
    EL VALLE GENTIAN VIOLET 
    gentian violet 1% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-373
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-373-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2023
    2NDC:55758-373-0215 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/202305/31/2023
    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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