Label: GASTRODIA ELATA PEPTIDE HAND SANITIZING- hand sanitizer 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 April 24, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic.

    Gastrodia elata Blume peptide 5.5% v/v. Purpose: bactericidal against Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli.

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

    Used for hand sanitizing and surgical hand sanitizing.

  • Warnings

    1. External use of disinfection gel. Ban on oral. Keep this container out of the reach of children.
    2. Avoid use with antagonistic drugs.
    3. Caution for allergic people.
    4. Keep away from the source of fire due to its inflammable.
    5. Seal, and store in a cool and dry place.

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
    • in the eyes. in case of contact, rinse eyes thoroughly with water
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    1.Sanitary hand disinfection: Take the right amount of this product on the palm, both hands rub each other to make uniform coating on each part for 1 minute.
    2. Surgical hand antisepsis: After surgical hand washing, apply proper amount of this product evenly to the skin of the forearm and the lower third of the upper arm of both hands and rub for 3 to 5 minutes until dry.

  • Other information

    Seal, and store in a cool and dry place.

  • Inactive ingredients

    Water, Glycerine.

  • Package Label - Principal Display Panel

    500G

  • INGREDIENTS AND APPEARANCE
    GASTRODIA ELATA PEPTIDE HAND SANITIZING 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75449-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GASTRODIA ELATA WHOLE (UNII: ZK2B063E7Q) (GASTRODIA ELATA WHOLE - UNII:ZK2B063E7Q) GASTRODIA ELATA WHOLE27.5 g  in 500 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75449-1001-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/24/2020
    Labeler - Tonghua Ren-Sheng-Yuan Biotechnology Co., Ltd (554530164)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tonghua Ren-Sheng-Yuan Biotechnology Co., Ltd554530164label(75449-1001) , manufacture(75449-1001)
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