Hand Sanitizer Gel by BERIOSKA S.L.

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by BERIOSKA S.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL- alcohol gel 
BERIOSKA S.L.

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Alcohol 70% w/w. Purpose: Antiseptic

Antiseptic, Hand Sanitizer

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

Apply on hands and rub until completely absorbed. Water is not needed.

• Supervise children under 6 years of age when using this product to avoid swallowing.

• in 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. If swallowed, get medical help or contact a Poison Control Center right away.

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

Keep out of reach of children.

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

glycerin, purified water USP, acrylates/C10-30 alkyl acrylate crosspolymer, PEG-40 hidrogenated castor oil, triethanolamine, CI 42090

HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78283-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	222.72299 mL  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78283-101-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2022	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/20/2022	12/31/2023

Labeler - BERIOSKA S.L. (462392556)

Registrant - BERIOSKA S.L. (462392556)

Establishment
Name	Address	ID/FEI	Business Operations
BERIOSKA S.L.		462392556	manufacture(78283-101)

Revised: 1/2024

Document Id: 0ea7a5d2-e591-08c4-e063-6294a90a45e0

34390-5

Set id: da3d25d0-2dd2-51ce-e053-2a95a90a6a6a

Version: 3

Effective Time: 20240111