Label: BIOVERA HAND SANITIZER WIPES- benzalkonium chloride liquid

  • 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 August 5, 2020

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  • Active ingredient

    Benzalkonium chloride 0.13% v/v. Purpose: Antimicrobial

  • Uses

    Hand sanitizer wipes to help reduce bacteria on the skin

  • Warnings

    For external use only. Do not use in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if skin irritation develops.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Open lid, gently pull out a wipe. Thoroughly wipe as desired. Allow to dry without wiping. Discard wipe in trash after use, do not flush in toilet.

  • Other Information

    Avoid extreme temperatures

  • Inactive ingredients

    citric acid, glycerin, lemongrass oil, water

  • Questions?

    1-888-964-3544, weekdays between 8:00 am and 5:00 pm CST

  • Purpose

    Antiseptic, Hand Sanitizer Wipe

  • Package label - Principal display panel

    3785 g NDC: 79748-407-80

  • INGREDIENTS AND APPEARANCE
    BIOVERA HAND SANITIZER WIPES 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79748-407(NDC:74869-426)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1274 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.63 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.15 g  in 100 g
    WATER (UNII: 059QF0KO0R) 99.02 g  in 100 g
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) 0.04435 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79748-407-80640 g in 1 CANISTER; Type 0: Not a Combination Product08/04/2020
    2NDC:79748-407-79400 g in 1 CANISTER; Type 0: Not a Combination Product08/04/2020
    3NDC:79748-407-811200 g in 1 CANISTER; Type 0: Not a Combination Product08/04/2020
    4NDC:79748-407-822400 g in 1 CANISTER; Type 0: Not a Combination Product08/04/2020
    5NDC:79748-407-832800 g in 1 CANISTER; Type 0: Not a Combination Product08/04/2020
    6NDC:79748-407-844000 g in 1 CANISTER; Type 0: Not a Combination Product08/04/2020
    7NDC:79748-407-854400 g in 1 CANISTER; Type 0: Not a Combination Product08/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/04/2020
    Labeler - Verataur, LLC. (117593664)
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