FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
BERIOSKA S.L.
Effective date
2022-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:43:53

Label at a glance#

ProductHand Sanitizer Gel
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% w/w. Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - WHEN USING SECTION

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

OTC - DO NOT USE SECTION

  • 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.

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER GEL 300ML USAHAND SANITIZER GEL 300ML USA

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78283-10178283-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
TROLAMINE9O3K93S3TKIACT

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
0ea7a5d2-e591-08c4-e063-6294a90a45e0da3d25d0-2dd2-51ce-e053-2a95a90a6a6a2024-01-11WarningsExact identifier
spl set id: da3d25d0-2dd2-51ce-e053-2a95a90a6a6a

Reported adverse events (FAERS/openFDA)#

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