Label: LINGRUI HAND ANTISEPTIC RINSE FREE- 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 27, 2020

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  • Active Ingredient(s)

    Ethanol 68% v/v. Purpose: Antiseptic

  • Purpose

    For hygienic hand antisepsis.

  • Use

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

  • Warnings

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

    1. Only external use, oral administration is prohibited.

    2. Keep out of reach of children.

    3. Those who are allergic to this product (alcohol, ethanol) are contraindicated.

  • 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

    Apply appropriate amount of this product to wash both hands and scrub for 1-3mins.

  • Other information

    Store in sealed, cool and dark condition.

  • Inactive ingredients

    Purified Water, Glycerol, Carbomer, Trolamine, Triclosan.

  • Package Label - Principal Display Panel

    42217-0115

    42217-0110

  • INGREDIENTS AND APPEARANCE
    LINGRUI HAND ANTISEPTIC RINSE FREE 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42217-0110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL40.6 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42217-0110-160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/27/2020
    LINGRUI HAND ANTISEPTIC RINSE FREE 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42217-0115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL340 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42217-0115-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/27/2020
    Labeler - Henan Lingrui Biopharmaceutical Co., Ltd (528000440)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Lingrui Biopharmaceutical Co., Ltd528000440label(42217-0115, 42217-0110) , manufacture(42217-0115, 42217-0110)
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