Label: BAISHICHEN- hand sanitizer gel 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 August 27, 2020

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • 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.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • 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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.

      Children under 6 years of age should be supervised when using products.
  • Other information

    Avoid freezing and excessive heat above 40C (104F)

    May discolor certain fabrics or surfaces

  • Inactive ingredients

    carbomer, glycerin, triethanolamine, water

  • Package Label - Principal Display Panel

    100 mL NDC:79808-111-03

    100 mL NDC:79808-111-03

  • INGREDIENTS AND APPEARANCE
    BAISHICHEN 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79808-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE C (ALLYL SUCROSE CROSSLINKED) (UNII: U990QE4LKP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHANOLAMINE PHOSPHATE (UNII: 4GH264P17A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79808-111-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
    2NDC:79808-111-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
    3NDC:79808-111-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
    4NDC:79808-111-04300 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
    5NDC:79808-111-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/27/2020
    Labeler - Yangzhou Huangxuan Daily Chemical Co Ltd (554537822)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Huangxuan Daily Chemical Co Ltd554537822manufacture(79808-111)
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