Label: BIOSHIELD 99 ALCOHOL- sanitizer spray
BIOSHIELD 99- citric acid, cinnamonoil 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 March 4, 2021

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

  • DOSAGE & ADMINISTRATION

    Product NDC: 81311-025:

    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.

  • INACTIVE INGREDIENT

    Product NDC: 81311-025:

    HYDROGEN PEROXIDE, GLYCERIN, CINNAMON OIL, ANHYDROUS CITRIC ACID, WATER

  • INDICATIONS & USAGE

    Product NDC: 81311-025:

    Use(s): Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • KEEP OUT OF REACH OF CHILDREN

    Product NDC: 81311-025:

    If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • PURPOSE

    Product NDC: 81311-025:

    Antiseptic

  • ACTIVE INGREDIENT

    Product NDC: 81311-025:

    Alcohol 80% v/v

  • WARNINGS

    Product NDC: 81311-025:

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

  • DO NOT USE

    Product NDC: 81311-025:

    in children less than 2 months of age • on open skin wounds

  • WHEN USING

    Product NDC: 81311-025:

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

  • STOP USE

    Product NDC: 81311-025:

    if irritation or rash occurs. These may be signs of a serious condition.

  • OTHER SAFETY INFORMATION

    Product NDC: 81311-025:

    Store between 15-30C (59-86F)

    • Avoid freezing and excessive heat above 40C (104F)

  • PRINCIPAL DISPLAY PANEL

    60 mL NDC: 81627-015-02

    2oz without alcohol

    300 mL NDC: 81627-015-10

    10oz without alcohol

    1000 mL NDC: 81627-015-32

    32oz without alcohol

    3785 mL NDC: 81627-015-50

    128oz without alcohol

    60 mL NDC: 81627-025-02

    2oz with alcohol

    300 mL NDC: 81627-025-10

    10oz with alcohol

    1000 mL NDC: 81627-025-32

    32oz with alcohol

    3785 mL NDC: 81627-025-50

    128oz with alcohol

  • INGREDIENTS AND APPEARANCE
    BIOSHIELD 99 ALCOHOL 
    sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81627-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81627-025-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2021
    2NDC:81627-025-10300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2021
    3NDC:81627-025-321000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2021
    4NDC:81627-025-503785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/04/2021
    BIOSHIELD 99 
    citric acid, cinnamonoil spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81627-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CINNAMON OIL (UNII: E5GY4I6YCZ) (CINNAMON OIL - UNII:E5GY4I6YCZ) CINNAMON OIL1 g  in 1000 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID5 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 940 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81627-015-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2021
    2NDC:81627-015-10300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2021
    3NDC:81627-015-321000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2021
    4NDC:81627-015-503785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/04/2021
    Labeler - Naturally Safe Solutions, LLC (130473517)
    Establishment
    NameAddressID/FEIBusiness Operations
    Naturally Safe Solutions, LLC130473517label(81627-015, 81627-025)
    Establishment
    NameAddressID/FEIBusiness Operations
    RPP PRODUCTS, INC.623623852manufacture(81627-015, 81627-025)