FDA.reportPublic FDA data

Hand sanitizer

Manufacturer
Physicians Formula
Effective date
2020-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:09:17

Label at a glance#

ProductHand sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Spray enough product on hands to cover completely Rub hands together until thoroughly dry Children under 6 years of age should be supervised when using this product

Storage and handling

Store below 110 F (43 C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only - do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughyl with water.

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

if irritation or rash occurs and lasts.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Other information

STORAGE AND HANDLING SECTION

Store below 110 F (43 C)

May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua/Eau), Fragrance (Parfum), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Portulaca Oleracea Extract, Aloe Barbadensis Leaf Juice, Potassium Sorbate, Sodium Benzoate, Citric Acid, Butylene Glycol, Red 40 (CI 16035)

Directions

DOSAGE & ADMINISTRATION SECTION

Spray enough product on hands to cover completely

Rub hands together until thoroughly dry

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31645-216-012021-07-23C16284748780-1c7ccaba7-1f8c-fd44-e053-dadaa90aa01bRose Take the Germs Away Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
31645-21631645-216-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALOE VERA LEAFZY81Z83H0XIACT
TEA TREE OILVIF565UC2GIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ALCOHOL3K9958V90MACTIB
SODIUM BENZOATEOJ245FE5EUIACT
FD&C RED NO. 40WZB9127XOAIACT
PORTULACA OLERACEA LEAF9JW9D9JGHZIACT

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
b2e8a168-1492-1ca9-e053-2a95a90a02baa2a8ab6a-4759-bd2f-e053-2a95a90ace7b2020-10-30WarningsExact identifier
spl id: b2e8a168-1492-1ca9-e053-2a95a90a02ba
spl set id: a2a8ab6a-4759-bd2f-e053-2a95a90ace7b

Reported adverse events (FAERS/openFDA)#

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