Label: HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS GREEN TEA AND CUCUMBER- ethyl alcohol gel

  • NDC Code(s): 71490-008-02, 71490-008-03
  • Packager: SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)
  • 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 February 21, 2023

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% V/V

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin. • recommended for repeated use.

  • Warnings

    Flammable, keep away from fire or flame.

    For external use only.

    When using this product
    • do not get into eyes. In case of contact, rinse eyes thoroughly with water.

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

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping.
    • supervise children in the use of this product.

  • Other information

    • store at 20° to 25°C (68° to 77°F). • may discolor certain fabrics.

  • Inactive ingredients

    acrylates (c10-30 alkyl acrylate crosspolymer), benzophenone-3, carbomer, cellulose, D&C Yellow No. 10, FD&C Blue No. 1, fragrance, glycerin, hydroxypropyl methylcellulose, lactose, retinyl palmitate (vitamin A palmitate), tocopheryl acetate (vitamin E acetate), triethanolamine, water (aqua).

  • Questions or comments?

    call   +1-419-322-4731
    available from Monday to Friday (8 am – 4 pm).
    You may report serious side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    NO WATER
    NO SOAP

    Manufactured for
    Sukhtian Households and Toiletries Manufacturing Co.

    by: Sukhtian Pharmaceutical Manufacturing
    Na'ur-Zaboud, AlQuds street,
    P.O BOX 1027, Amman, Jordan 11710.

    Made in Jordan

  • Packaging

    GreenTeaCucumber-008

  • INGREDIENTS AND APPEARANCE
    HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS GREEN TEA AND CUCUMBER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71490-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71490-008-02110 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2017
    2NDC:71490-008-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2017
    Labeler - SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) (557666494)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUKHTIAN PHARMACEUTICAL MANUFACTURING850389249manufacture(71490-008)
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