Label: BAC-D HAND SANITIZER- alcohol spray

  • 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 3, 2022

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 80% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • DOSAGE & ADMINISTRATION

    Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing

  • STORAGE AND HANDLING

    Other information Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, hydrogen peroxide, purified water USP

  • WARNINGS

    Warnings

    For external use only. Flammable. Keep away from heat or flame.

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

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • SPL UNCLASSIFIED SECTION

    Mfd. in the USA by AEC Consumer Products

    135 Airport Rd, Fayetteville, NC 28306

    1-888-232-3344 • www.BAC-D.com

    80% ALCOHOL

    MAXIMUM STRENGTH

    FAST & EFFECTIVE

    KILLS 99.99% OF MOST ILLNESS-CAUSING GERMS

    Misting Spray

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    BAC-D HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86089-900
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86089-900-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - AEC CONSUMER PRODUCTS (080994102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(86089-900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holly Oak Chemical, Inc.057840035manufacture(86089-900) , pack(86089-900)