FDA.reportPublic FDA data

One Dose Pharm

Manufacturer
Vialen SRL
Effective date
2021-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:19:46

Label at a glance#

ProductOne Dose Pharm
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

Store between 15–30°C (59-86F°) Avoid freezing or heat above 40°C (104F°)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% V/V Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Aseptic, Hand Sanitizer

OTC - STOP USE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use in children less than 2 months of age or open skin wounds.

OTC - WHEN USING SECTION

When using this product Keep out of the eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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 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.

Other Information

STORAGE AND HANDLING SECTION

Store between 15–30°C (59-86F°)

Avoid freezing or heat above 40°C (104F°)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, glycerine, carbomer, triethanolamine, Aloe barbadensis leaf juice

Package Label. Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

One Dose PharmOne Dose Pharm

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77922-062677922-0626-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
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
d4742392-313e-194e-e053-2995a90afa38abaffbf7-5f5e-e8e2-e053-2a95a90ab9132021-12-31WarningsExact identifier
spl id: d4742392-313e-194e-e053-2995a90afa38
spl set id: abaffbf7-5f5e-e8e2-e053-2a95a90ab913

Reported adverse events (FAERS/openFDA)#

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