Label: BELSON HAND SANITIZER- alcohol gel

  • 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 8, 2020

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

  • ACTIVE INGREDIENT

    ALCOHOL 70.0 w%

  • INACTIVE INGREDIENTS

    Water, Carbomer, Tetrahydroxypropyl Ethylenediamine, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil,

    Hedera Helix (Ivy) Stem Extract, Salvia Officinalis (Sage) Extract

  • PURPOSE

    SANITIZER

  • WARNINGS

    1. Do not use on the following body parts.

    Around the eyes and ears, in the oral cavity, a wide range of body parts and damaged skin (may have irritating effects)

    2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
    1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
    2) Skin irritation symptoms

    3. Other precautions
    1) For external use only (do not underwear).
    2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
    3) Be careful not to inhale vapor when using it extensively or for a long time (if you drink ethanol vapor in large quantities or repeatedly, irritation to the mucous membrane, headache, etc. may occur). (Only for products containing ethanol)
    4) When repeated use on the same site, be careful as the skin may become rough due to degreasing.
    5) When used in sealed bandages, cast bandages, packs, etc., irritation symptoms may appear.
    6) Do not use this medicine for anal or vaginal poultry as it may cause irritation or chemical burns.
    7) Do not use for any purpose.

    4. Precautions for storage
    1) Avoid shading and keep it in shading.
    2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
    3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign objects.
    4) Taking it out of the original container and storing it in another container may cause accidents due to misuse or deterioration in quality, so store it in the original container.

  • KEEP OUT OF REACH OF CHILDREN

    Keep it out of reach of children, and if a child swallows it, go to the hospital right away.

  • Uses

    Uses:
    Disinfection of hands and skin

  • Directions

    Directions:
    Take an appropriate amount on your hands and rub thoroughly to dry.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    BELSON HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74002-5050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETOL (UNII: Q4R969U9FR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74002-5050-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - DongbangCosmetics Co., ltd. (694452564)
    Registrant - DongbangCosmetics Co., ltd. (694452564)
    Establishment
    NameAddressID/FEIBusiness Operations
    DongbangCosmetics Co., ltd.694452564manufacture(74002-5050)