Label: BYD CARE HAND SANITIZER XD-A04- alcohol gel

  • NDC Code(s): 73818-201-02
  • Packager: Shanwei BYD Industrial Co Ltd
  • 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 January 13, 2022

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  • Misc.

    Model: XD-A04

    Distributed by Global Healthcare Product Solutions, LLC

    1 (800) 293-2886

    Manufactured by:

    Shanwei BYD Industrial Co., Ltd.

    Shanwei High-Tech Development Zone, Shanwei, China

    Tel: +86-755-89888888

    Website: www.byd.com 500-1

  • Active Ingredient:

    Alcohol 72% (V/V) 500-2

  • Purpose:

    Antiseptic 500-3

  • Uses:

    500-4To Help decrease germs on the skin that could cause disease. Recommended for repeated use.

  • Warnings:

    For external use only: hands

    Flammable, Keep away from fire or flame. 500-5

  • When using this product:

    • Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.
    • Do not inhale or ingest.
    • Use with caution if allergic.
      500-6
  • When using this product:

    • 500-7
      Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.
    • Do not inhale or ingest.
    • Use with caution if allergic.
  • Stop use and ask a doctor if:

    • Irritation or redness develops.
    • Condition persists for more than 72 hours.
      500-8
  • Keep out of reach of children:

    If swallowed, get medical help or contact a Poison Control Center right away. 500-9

  • Directions:

    • Wet hands thoroughly without wiping until they are dry.
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.
      500-10
  • Other information:

    • After unseal, tighten the cap and use product within the validity period.
    • After use, seal and keep away from light and moisture.
    • Store in a cool and dry place. Do not store above 37 oC (98.6 oF).
      500-11
  • Inactive ingredients:

    Arcylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethylpropanol, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Tocopheryl Acetate, Water 500-12

  • Package Label - Principal Display Panel

    500-13

  • INGREDIENTS AND APPEARANCE
    BYD CARE HAND SANITIZER XD-A04 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73818-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.8 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.15 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 21.9 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 1 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.05 mL  in 100 mL
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO) 0.3 mL  in 100 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 3.8 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73818-201-02500 mL in 1 BAG; Type 1: Convenience Kit of Co-Package06/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/05/2020
    Labeler - Shanwei BYD Industrial Co Ltd (552102846)
    Registrant - Shanwei BYD Industrial Co Ltd (552102846)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanwei BYD Industrial Co Ltd552102846manufacture(73818-201) , label(73818-201) , pack(73818-201)
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