BIOSHIELD 99 ALCOHOL- sanitizer spray BIOSHIELD 99- citric acid, cinnamonoil spray

BioShield 99 by

Drug Labeling and Warnings

BioShield 99 by is a Otc medication manufactured, distributed, or labeled by Naturally Safe Solutions, LLC, RPP PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

300 mL NDC: 81627-015-10

1000 mL NDC: 81627-015-32

3785 mL NDC: 81627-015-50

60 mL NDC: 81627-025-02

300 mL NDC: 81627-025-10

1000 mL NDC: 81627-025-32

3785 mL NDC: 81627-025-50

INGREDIENTS AND APPEARANCE

BIOSHIELD 99 ALCOHOL 
sanitizer spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81627-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	800 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMON OIL (UNII: E5GY4I6YCZ)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81627-025-02	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/04/2021
2	NDC: 81627-025-10	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/04/2021
3	NDC: 81627-025-32	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/04/2021
4	NDC: 81627-025-50	3785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/04/2021

BIOSHIELD 99 
citric acid, cinnamonoil spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81627-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CINNAMON OIL (UNII: E5GY4I6YCZ) (CINNAMON OIL - UNII:E5GY4I6YCZ)	CINNAMON OIL	1 g  in 1000 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	5 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	940 mL  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81627-015-02	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/04/2021
2	NDC: 81627-015-10	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/04/2021
3	NDC: 81627-015-32	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/04/2021
4	NDC: 81627-015-50	3785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/04/2021

Labeler - Naturally Safe Solutions, LLC (130473517)

Establishment
Name	Address	ID/FEI	Business Operations
Naturally Safe Solutions, LLC		130473517	label(81627-015, 81627-025)

Establishment
Name	Address	ID/FEI	Business Operations
RPP PRODUCTS, INC.		623623852	manufacture(81627-015, 81627-025)