Label: ANVI- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 November 17, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride .13%..... Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use(s)

    Hand and skin sanitizer to decrease microbes on the skin. For use when hand washing is not available.

  • Warnings

    For external use only. Keep out of ears, eyes or mouth. In case of contact with eyes, flush with water.

    Stop use and ask doctor: If redness or irritation develops and persists for more than 72 hours.

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

  • Do not use

    Stop use and ask a doctor: If redenss or irritation develops and persists for more than 72 hours.

  • Directions

    Directions: Dispense an adequate amount into palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.

    Other Information: Skin cells may shed naturally or by abrasion prior to four hours, exposing fresh, unprotected skin. Reapply as needed.

  • Stop Use and ask a doctor

    Stop use and ask a doctor: If redness or irritation develops and persists 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: Dispense an adequate amount into palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.

  • Directions for Use

    Directions: Dispense an adequate amount into palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.

    Other Information: Skin cells may shed naturally or by abrasion prior to four hours, exposing fresh, unprotected skin. Reapply as needed.

  • Other information

    Other Information: Skin cells may shed naturally or by abrasion prior to four hours, exposing fresh, unprotected skin. Reapply as needed.

  • Inactive ingredients

    Water. Colloidal Silicon Dioxide

  • Questions-Information

    www.getanvi.com

  • Principal Display Panel

    59.15 ml2 oz (59.14 mL) NDC 80201-100-01

  • INGREDIENTS AND APPEARANCE
    ANVI 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80201-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.2 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 99.67 g  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80201-200-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/26/2020
    2NDC:80201-200-02108 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    3NDC:80201-200-04237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    4NDC:80201-200-03167 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    5NDC:80201-200-05473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    6NDC:80201-200-06946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    7NDC:80201-200-073785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    8NDC:80201-200-09208173 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2020
    9NDC:80201-200-101040864 mL in 1 CONTAINER; Type 0: Not a Combination Product08/26/2020
    10NDC:80201-200-0818925 mL in 1 PAIL; Type 0: Not a Combination Product08/26/2020
    11NDC:80201-200-2150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/26/2020
    Labeler - Anvi LLC (117619678)
    Registrant - Anvi LLC (117619678)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anvi LLC117619678manufacture(80201-200)
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