FDA.reportPublic FDA data

BioShield 99

Manufacturer
Naturally Safe Solutions, LLC | RPP PRODUCTS, INC.
Effective date
2021-03-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:56

Label at a glance#

ProductBioShield 99 Alcohol
Active ingredientALCOHOL, CINNAMON OIL, CITRIC ACID MONOHYDRATE
Label structure12 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Product NDC: 81311-025:

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

INDICATIONS & USAGE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Product NDC: 81311-025:

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

OTC - PURPOSE SECTION

Product NDC: 81311-025:

Antiseptic

OTC - ACTIVE INGREDIENT SECTION

Product NDC: 81311-025:

Alcohol 80% v/v

WARNINGS SECTION

Product NDC: 81311-025:

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

OTC - DO NOT USE SECTION

Product NDC: 81311-025:

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

OTC - WHEN USING SECTION

Product NDC: 81311-025:

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

OTC - STOP USE SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 81627-015-02

2oz without alcohol2oz without alcohol

300 mL NDC: 81627-015-10

10oz without alcohol10oz without alcohol

1000 mL NDC: 81627-015-32

32oz without alcohol32oz without alcohol

3785 mL NDC: 81627-015-50

128oz without alcohol128oz without alcohol

60 mL NDC: 81627-025-02

2oz with alcohol2oz with alcohol

300 mL NDC: 81627-025-10

10oz with alcohol10oz with alcohol

1000 mL NDC: 81627-025-32

32oz with alcohol32oz with alcohol

3785 mL NDC: 81627-025-50

128oz with alcohol128oz with alcohol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN2
1241663ethanol 0.8 ML/ML Topical SpraySCD2
1241663ethanol 80 % Topical SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81627-015-022022-07-29C16284748780-1e4f33bdf-9ba9-d8a0-e053-dadaa90a6e4eProduct 81627-015 Active Ingredients: ALCOHOL Product 81627-025 Active Ingredients: CITRIC ACID MONOHYDRATE, CINNAMON OIL
81627-015-102022-07-29C16284748780-1e4f33bdf-9ba9-d8a0-e053-dadaa90a6e4eProduct 81627-015 Active Ingredients: ALCOHOL Product 81627-025 Active Ingredients: CITRIC ACID MONOHYDRATE, CINNAMON OIL
81627-015-322022-07-29C16284748780-1e4f33bdf-9ba9-d8a0-e053-dadaa90a6e4eProduct 81627-015 Active Ingredients: ALCOHOL Product 81627-025 Active Ingredients: CITRIC ACID MONOHYDRATE, CINNAMON OIL
81627-015-502022-07-29C16284748780-1e4f33bdf-9ba9-d8a0-e053-dadaa90a6e4eProduct 81627-015 Active Ingredients: ALCOHOL Product 81627-025 Active Ingredients: CITRIC ACID MONOHYDRATE, CINNAMON OIL
81627-025-022022-07-29C16284748780-1e4f33bdf-9ba9-d8a0-e053-dadaa90a6e4eProduct 81627-015 Active Ingredients: ALCOHOL Product 81627-025 Active Ingredients: CITRIC ACID MONOHYDRATE, CINNAMON OIL
81627-025-102022-07-29C16284748780-1e4f33bdf-9ba9-d8a0-e053-dadaa90a6e4eProduct 81627-015 Active Ingredients: ALCOHOL Product 81627-025 Active Ingredients: CITRIC ACID MONOHYDRATE, CINNAMON OIL
81627-025-322022-07-29C16284748780-1e4f33bdf-9ba9-d8a0-e053-dadaa90a6e4eProduct 81627-015 Active Ingredients: ALCOHOL Product 81627-025 Active Ingredients: CITRIC ACID MONOHYDRATE, CINNAMON OIL
81627-025-502022-07-29C16284748780-1e4f33bdf-9ba9-d8a0-e053-dadaa90a6e4eProduct 81627-015 Active Ingredients: ALCOHOL Product 81627-025 Active Ingredients: CITRIC ACID MONOHYDRATE, CINNAMON OIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81627-015-02BioShield 9960 mL in 1 BOTTLE, SPRAYSPRAY602
81627-015-10BioShield 99300 mL in 1 BOTTLE, SPRAYSPRAY3002
81627-015-32BioShield 991000 mL in 1 BOTTLE, SPRAYSPRAY10002
81627-015-50BioShield 993785 mL in 1 BOTTLE, SPRAYSPRAY37852
81627-025-02BioShield 99 Alcohol60 mL in 1 BOTTLE, SPRAYSPRAY602
81627-025-10BioShield 99 Alcohol300 mL in 1 BOTTLE, SPRAYSPRAY3002
81627-025-32BioShield 99 Alcohol1000 mL in 1 BOTTLE, SPRAYSPRAY10002
81627-025-50BioShield 99 Alcohol3785 mL in 1 BOTTLE, SPRAYSPRAY37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81627-015BIOSHIELD 99 ALCOHOL (SANITIZER) SPRAY BIOSHIELD 99 (CITRIC ACID, CINNAMONOIL) SPRAY [NATURALLY SAFE SOLUTIONS, LLC]2Legacy NDC, 4 package rows20210312_bcbe2834-a02a-6bd4-e053-2995a90aeb84.zip
81627-025BIOSHIELD 99 ALCOHOL (SANITIZER) SPRAY BIOSHIELD 99 (CITRIC ACID, CINNAMONOIL) SPRAY [NATURALLY SAFE SOLUTIONS, LLC]2Legacy NDC, 4 package rows20210312_bcbe2834-a02a-6bd4-e053-2995a90aeb84.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81627-01581627-015-02, 81627-015-10, 81627-015-32, 81627-015-50
81627-02581627-025-02, 81627-025-10, 81627-025-32, 81627-025-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CINNAMON OILE5GY4I6YCZIACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CINNAMON OILE5GY4I6YCZACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bcbe2876-3240-5c5c-e053-2995a90a6508bcbe2834-a02a-6bd4-e053-2995a90aeb842021-03-04WarningsExact identifier
spl id: bcbe2876-3240-5c5c-e053-2995a90a6508
spl set id: bcbe2834-a02a-6bd4-e053-2995a90aeb84

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.