Hand Sanitizer by Biogennix / Santa Croce, LLC

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Biogennix, Santa Croce, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
Biogennix

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.

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Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Antiseptic

Use

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

Warnings

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

Do not use

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

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

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.

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 ingredients

glycerin, hydrogen peroxide, purified water USP

Other Information

Store between 15-30°C (59-86°F)

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

100ml NDC: 77080-001-21 250ml NDC: 77080-001-31 500ml NDC: 77080-001-41 3785ml NDC: 77080-001-11

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77080-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77080-001-12	1 in 1 BOX	03/30/2020	04/17/2023
1	NDC: 77080-001-11	3785 mL in 1 JUG; Type 0: Not a Combination Product
2	NDC: 77080-001-24	2 in 1 BOX	03/30/2020	04/17/2023
2	NDC: 77080-001-21	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 77080-001-22	4 in 1 BOX	03/30/2020	04/17/2023
3	NDC: 77080-001-21	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
4	NDC: 77080-001-23	12 in 1 BOX	03/30/2020	04/17/2023
4	NDC: 77080-001-21	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
5	NDC: 77080-001-32	2 in 1 BOX	03/30/2020	04/17/2023
5	NDC: 77080-001-31	250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
6	NDC: 77080-001-33	4 in 1 BOX	03/30/2020	04/17/2023
6	NDC: 77080-001-31	250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
7	NDC: 77080-001-42	2 in 1 BOX	03/30/2020	04/17/2023
7	NDC: 77080-001-41	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
8	NDC: 77080-001-43	4 in 1 BOX	03/30/2020	04/17/2023
8	NDC: 77080-001-41	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	04/17/2023

Labeler - Biogennix (832270370)

Establishment
Name	Address	ID/FEI	Business Operations
Santa Croce, LLC		051879429	manufacture(77080-001)

Establishment
Name	Address	ID/FEI	Business Operations
Biogennix		832270370	relabel(77080-001) , repack(77080-001)

Revised: 2/2021

Document Id: bb7e28cd-68c7-24d8-e053-2a95a90ae5c0

34390-5

Set id: a5a32aae-506c-6de9-e053-2995a90ad632

Version: 5

Effective Time: 20210216