FDA.reportPublic FDA data

Standard Hand Sanitizer

Manufacturer
COSMETIC DEVELOPMENT LABS, LLC
Effective date
2020-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:38:19

Label at a glance#

ProductStandard Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Sanitizer to reduce bacteria on the skin that could cause disease Recommended for repeated use

Dosage and administration

Dispense enough sanitizer to cover desired areas Rub product into skin until dry Children under 6 years of age should be supervised when using this product

Storage and handling

Store at a temperature below 110ºF (43ºC) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Hand Sanitizer

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol, 62% v/v

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Sanitizer to reduce bacteria on the skin that could cause disease

Recommended for repeated use

Warnings

WARNINGS SECTION

Flammable. Keep away from sources of heat, fire or flame.
For external use only.
When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or redness develops and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - WHEN USING SECTION

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation or redness develops and lasts.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Dispense enough sanitizer to cover desired areas

Rub product into skin until dry

Children under 6 years of age should be supervised when using this product

INACTIVE INGREDIENT SECTION

Water, Aminomethyl Propanol, Carbomer, Methyl Gluceth-20

STORAGE AND HANDLING SECTION

Store at a temperature below 110ºF (43ºC)

May discolor certain fabrics or surfaces

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sample LabelSample Label

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
74106-74774106-747-08

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
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
METHYL GLUCETH-20J3QD0LD11PIACT
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
a1df6bfa-7cd5-f1b3-e053-2995a90ac11da1df6bfa-7cd4-f1b3-e053-2995a90ac11d2020-04-01WarningsExact identifier
spl id: a1df6bfa-7cd5-f1b3-e053-2995a90ac11d
spl set id: a1df6bfa-7cd4-f1b3-e053-2995a90ac11d

Reported adverse events (FAERS/openFDA)#

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