FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SAMARA COSMETICS S.A.S.
Effective date
2020-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:31

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Uses * Helps eliminate bacterias on the hand. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin

Dosage and administration

Directions: Place enough product in your palm to throughly cover your hands. Rub hands together briskly until dry

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

Uses

* Helps eliminate bacterias on the hand. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

  • Ethyl Alcohol 65%...................................Antiseptic

Warnings

WARNINGS SECTION

  • For external use only-
  • When using this product keep out o f eyes. In case of contact, flush with water several minutes.
  • Keep out of reach of children except under adult supervision
  • If swalow get medical help or contact a Poison Control Center right away.
  • Flammable: Keep away from heat and flame.
  • Stop use and ask Doctor: if skin irritation develops.
  • Do not swalow
  • Children under 6 years old should be supervised when using this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

* Irritation develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of incidental ingestion, see professional advice or contact a Poison Control Center inmediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Place enough product in your palm to throughly cover your hands.
  • Rub hands together briskly until dry

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water Carbomer, Triethanolamine, Olea Europaea Fruit Oil, Panthenol, Glycerin, Aloe Barbadensis Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower/Leaf Extract, Rosmarinus Officinalis Leaf Extract, Thymus Vulgaris Leaf Oil, Linum Usitatissimum Seed Oil, Tocopheryl acetate (Vitamina E), Hydroxypropyl methylcellulose, Ethyl Lauroyl Arginate, Propylene Glycol, Fragrance, Phenoxyethanol, Ethylhexylglycerin, Citric Acid

Questions?

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS: (574) 4448438 Ext 108 (Monday to Friday) 6:30 am to 4:30 pm (UTC/GMT 5 hours)

Uses

OTC - PURPOSE SECTION

Uses

* Helps eliminate bacteria on the hand. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin

Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79894-004-012023-01-30C16284748780-1f386c64a-3dcc-0266-e053-dadaa90a7c1aHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79894-004-01Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79894-004HAND SANITIZER (ALCOHOL) GEL [SAMARA COSMETICS S.A.S.]1Legacy NDC, 1 package rows20200802_abd5b1ef-5a23-ebec-e053-2995a90af0fa.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79894-00479894-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
OLEA EUROPAEA FRUIT VOLATILE OIL8E7358CX1JIACT
PANTHENOLWV9CM0O67ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
THYMUS VULGARIS LEAFGRX3499643IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYPROMELLOSES3NXW29V3WOIACT
PROPANEDIOL5965N8W85TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
ROSMARINUS OFFICINALIS FLOWERNR1A27F29OIACT
LINUM USITATISSIMUM WHOLE310OJT00CGIACT
ETHYL LAUROYL ARGINATE HYDROCHLORIDEXPD6ZY79TBIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
GLYCERINPDC6A3C0OXIACT
CAMELLIA OILT1PE06G0VEIACT

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
abd5b1fa-d564-3897-e053-2995a90aae9fabd5b1ef-5a23-ebec-e053-2995a90af0fa2020-08-01WarningsExact identifier
spl id: abd5b1fa-d564-3897-e053-2995a90aae9f
spl set id: abd5b1ef-5a23-ebec-e053-2995a90af0fa

Reported adverse events (FAERS/openFDA)#

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