Label: BELSON HAND SANITIZER ETHANOL 75 PERCENT TISSUE- alcohol liquid

  • 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 15, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL 75.0 w%

  • INACTIVE INGREDIENTS

    Water, PEG-60 Hydrogenated Castor Oil, Lavandula Angustifolia (Lavender) Oil, Butylene Glycol, Aloe Barbadensis Extract, Chamomilla Recutita (Matricaria) Oil, Sodium Benzoate, Hexylene Glycol, Rosmarinus Officinalis (Rosemary) Extract

  • PURPOSE

    SANITIZER

  • WARNINGS

    1. Do not use on body parts such as: Around the eyes and ears, inside of the mouth, broad areas of the body or damaged skin (can cause irritation)
    2. Stop using immediately and consult your doctor or pharmacist if any of the following symptoms occur: 1) Rash, redness, itchiness, edema, or other hypersensitivities 2) Skin irritation
    3. Other precautions when using 1) Only for external use (do not ingest). 2) Keep away from the eyes and rinse thoroughly with clean water before consulting your doctor or pharmacist when it gets in your eyes. 3) When applying broadly or for long periods of time, do not breathe in the product vapor excessively (irritation on the mucous membrane or a headache may occur when ethanol vapor is breathed in excessive amounts or repetitively). 4) Be careful of rough skin caused by fat removal when applying repetitively on the same area. 5) Do not use on occlusive dressing, cast, or pack, for it may cause irritation. 6) Do not use on the anus or vagina, for it may cause chemical burns. 7) Do not use for anything other than the designated purposes.
    4. Precautions for storing 1) Avoid fires and store away from direct sunlight. 2) Keep away from children and go to the hospital immediately in case of ingestion. 3) Close the lid completely so that the product does not dry out or foreign materials cannot enter. 4) Keep in the original container, for removing and storing the product in another container can cause decreased functions or accidents due to misuse.

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children and go to the hospital immediately in case of ingestion.

  • Uses

    Sanitization of hands, skin, etc.

  • Directions

    ■ Wet hands thoroughly with product and allow to dry without wiping
    ■ Do not flush
    ■ Children under 2 years ask a doctor before use

  • Other lnformation

    ■ Read the directions and warnings before use
    ■ Store between 15-30℃(59-89℉)
    ■ Avoid freezing and excessive heat above 40℃(104 ℉)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of container

  • INGREDIENTS AND APPEARANCE
    BELSON HAND SANITIZER ETHANOL 75 PERCENT TISSUE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74002-3040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    PEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    ROSEMARY (UNII: IJ67X351P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74002-3040-1124 g in 1 CONTAINER; 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.,LTD694452564manufacture(74002-3040)