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 23:23:32

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product in your palm to throughly cover your hands. Rub hands together briskly until dry Apply it on the parts of the body that needs to be cleaned and rub it briskly until dry

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 68% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

* Helps eliminate bacteria on the hand and parts of the body that needs to be cleaned. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin

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

Do not use

OTC - DO NOT USE SECTION

Stop use and ask a doctor if

* Irritation develops

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to throughly cover your hands.
  • Rub hands together briskly until dry
  • Apply it on the parts of the body that needs to be cleaned and rub it briskly until dry

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water. citric acid, propanediol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286291ethanol 68 % Topical SolutionPSN1
2286291ethanol 0.68 ML/ML Topical SolutionSCD1
2286291ethanol 68 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79894-008-012023-01-30C16284748780-1f386c649-c893-0266-e053-dadaa90a7c1aHAND SANITIZER LIQUID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79894-008-01Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79894-008HAND SANITIZER (ALCOHOL) LIQUID [SAMARA COSMETICS S.A.S.]1Legacy NDC, 1 package rows20200802_abd63638-e547-014e-e053-2995a90adbe5.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79894-00879894-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
abd635c6-256d-e665-e053-2995a90a4cc3abd63638-e547-014e-e053-2995a90adbe52020-08-01WarningsExact identifier
spl id: abd635c6-256d-e665-e053-2995a90a4cc3
spl set id: abd63638-e547-014e-e053-2995a90adbe5

Reported adverse events (FAERS/openFDA)#

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