Label: TONGYI CLEANGUARD HAND SANITIZER- hand sanitizer gel

  • 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 April 1, 2020

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

  • Active ingredient

    Ethanol

  • Inactive ingredient

    Water

    Acrylate

  • Purpose

    Effectively kill intestinal pathogenic bacteria, pyogenic coccus, pathogenic yeast and common pathogenic bacteria in hospital.

  • When using

    Effectively kill intestinal pathogenic bacteria, pyogenic coccus, pathogenic yeast and common pathogenic bacteria in hospital.

  • Do not use

    Use only as directed.
    Do not use for cases not directed.

  • Stop use

    Stop use if the product's volatile gases cause discomfort, or if you experience respiratory irritation such as cough, asthma, or difficulty breathing.

  • Ask doctor

    If using the product causes serious discomfort, ask or see your doctor.

  • Ask doctor/pharmacist

    If using the product causes serious discomfort, ask or see your doctor/pharmacist.

  • Keep out of reach of children

    Keep out of reach of children.

  • Questions

    Please contact with us at the phone number +86-10-61238999 when you have any questions.

  • Pregnancy or breast feeding

    Pregnant or breast feeding women shall follow doctor advice.

  • Indications & usage

    1. Hygiene hand disinfection: take an appropriate amount of instant hand sanitizing gel on the palm of your hand, rub your hands for 1 minute.

    2. Surgical hand disinfection: wash and dry the lower 1/3 of the hands, forearms and upper arms with soap or antibacterial hand sanitizer according to the instruction, and then apply 5-10ml of this product evenly to the hands, forearms and lower 1/3 of the upper arms. Rub the skin to dryness and wait for 3 minutes before wearing sterile gloves.

  • Dosage & administration

    Use it as needed, after following the usage instructions.

    For external use only.

  • Dosage forms & strengths

    This product is gel dosage form.
    The active ingredient strength is 70%.

  • Warnings

    1. For external use and shall not be taken orally; keep out of reach of children.

    2. Use with caution if allergic to alcohol; Seek for timely medical treatment if untoward reaction occurs in the use.

    3. This product contains alcohol, avoid open flames; keep tightly closed in a cool place.

    4. Keep away from the eyes, do not rub the eyes if accidental contact, rinse the eyes thoroughly with water for 15 minutes. If the situation worsens or irritation continues, seek medical treatment. Do not induce vomiting if swallow occurs, see medical treatment from hospital or poison control center.

    5. This product should not be used for damaged skin. For external use only, avoid entering into the eyes.

  • Package label. Principal display panel

    6061

  • INGREDIENTS AND APPEARANCE
    TONGYI CLEANGUARD HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73681-6061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL42 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,3-BUTYLENEGLYCOL DIMETHACRYLATE (UNII: OL56191M6N) 5 mL  in 60 mL
    WATER (UNII: 059QF0KO0R) 15 mL  in 60 mL
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73681-6061-796 in 1 BOX04/01/2020
    1NDC:73681-6061-160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2020
    Labeler - Tongyi Petroleum Chemical Co., Ltd. (544924178)
    Registrant - Tongyi Petroleum Chemical Co., Ltd. (544924178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tongyi Petroleum Chemical Co., Ltd.544924178label(73681-6061) , manufacture(73681-6061)