Label: BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 79096-002-03, 79096-002-05, 79096-002-10, 79096-002-12, view more
    79096-002-15, 79096-002-18, 79096-002-20, 79096-002-25, 79096-002-30, 79096-002-50, 79096-002-70, 79096-002-80
  • Packager: G.v. Cosmetics 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 October 12, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.1%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses • hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame
    For external use only

    Do not use • in children less than 2 months of age • on open skin wounds

    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 develop • condition persists for more than 72 hours

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

  • DOSAGE & ADMINISTRATION

    Directions • wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

  • STORAGE AND HANDLING

    Other information • store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

  • INACTIVE INGREDIENT

    Inactive ingredients alpha-isomethyl ionone, benzethonium chloride, benzyl salicylate, citronellol, cocamidopropyl betaine, ethyl alcohol, FD&C Blue no. 1, fragrance, hexyl cinnamal, hydroxycitronellal, limonene, linalool, propylene glycol, sodium lauryl sulfoacetate, tocopheryl acetate, water

  • SPL UNCLASSIFIED SECTION

    Without soap or water
    No rinse - no fuss

    No sticky residue

    HYGIENIC

    BIOTOP®

    PROFESSIONAL

    Manufactured by: G.V. Cosmetics Ltd.
    34 Ben-Zion Galis St. Segula, Petach
    Tikva, Israel 4927934
    Made In Israel

    You may also report serious side effects to this address.

    BIOTOP PROFESSIONAL USA, INC. 2723 W Touhy Ave,
    Chicago, IL 60645
    www.biotopworld.com | Info@biotopworld.com

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79096-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79096-002-0330 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    2NDC:79096-002-0550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    3NDC:79096-002-7070 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    4NDC:79096-002-8080 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    5NDC:79096-002-10100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    6NDC:79096-002-12120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    7NDC:79096-002-15150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    8NDC:79096-002-18180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    9NDC:79096-002-20200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    10NDC:79096-002-25250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    11NDC:79096-002-30300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    12NDC:79096-002-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/13/2020
    Labeler - G.v. Cosmetics Ltd (649551330)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.V. COSMETICS LTD649551330manufacture(79096-002)