Label: BIOSHIELD 99 ALCOHOL- sanitizer spray
BIOSHIELD 99- citric acid, cinnamonoil spray
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Contains inactivated NDC Code(s)
NDC Code(s): 81627-015-02, 81627-015-10, 81627-015-32, 81627-015-50, view more81627-025-02, 81627-025-10, 81627-025-32, 81627-025-50 - Packager: Naturally Safe Solutions, LLC
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIOSHIELD 99 ALCOHOL
sanitizer sprayProduct 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 sprayProduct 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)