Label: HONGDONGSAM DONGAN-BE- fermented vinegar base soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 18, 2024

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

  • ACTIVE INGREDIENT

    fermented vinegar base 93.2%

  • INACTIVE INGREDIENT

    white vinegar 4%, jojoba oil 1%, acacia scent 0.8%, sulfur hot spring water concentrate 1%

  • PURPOSE

    acne, seborrheic dermatitis

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Make a lot of foam, wash it, and rinse with warm water after 2-3 minutes

  • WARNINGS

    For external use only

    When using this product

    ■ if following abnormal symptoms persist, discontinue use

    Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

    ■ Stop immediately and consult a doctor if you experience

    1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

    2) Skin Irritation

    3) Following Instructions when using medication

    (1) For external use only (Do not use internally)

    (2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

    ■ Be careful not to inhale or use excessively for a long

  • DOSAGE & ADMINISTRATION

    for topical use

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HONGDONGSAM DONGAN-BE 
    fermented vinegar base soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84954-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APPLE CIDER VINEGAR (UNII: 0UE22Q87VC) (APPLE CIDER VINEGAR - UNII:0UE22Q87VC) APPLE CIDER VINEGAR93.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84954-0002-1750 mL in 1 PACKAGE; Type 0: Not a Combination Product11/10/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/10/2024
    Labeler - Hyosungwon (987424933)
    Registrant - Hyosungwon (987424933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Agricultural Corporation YUBIMUHUAN CO Ltd695152747manufacture(84954-0002)