FDA.reportPublic FDA data

Roots

Manufacturer
MFG Chemical, LLC.
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:28:27

Label at a glance#

ProductRoots
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Place enough product in your palm to cover hands and rub hands together until dry. Children under 6 years of age should be supervised when using hand sanitizer.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Ethyl Alcohol 80% v/v............................................................................................................................................................. Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Hand Sanitizer to help reduce bacteria on the skin

OTC - PURPOSE SECTION

Warnings

WARNINGS SECTION

Flammable. Keep away from heat 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 rash appears and lasts.

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

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 cover hands and rub hands together until dry.
  • Children under 6 years of age should be supervised when using hand sanitizer.

Other Information

OTHER SAFETY INFORMATION

  • Store below 110°F (43°C)
  • May discolor certain fabric or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Tert-butanol, Glycerin, Polyacrylate, Aminomethyl Propanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

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
77809-08077809-080-02

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
ALCOHOL3K9958V90MACTIB
TERT-BUTYL ALCOHOLMD83SFE959IACT
WATER059QF0KO0RIACT
POLYACRYLIC ACID (800000 MW)D0I6NSZ87UIACT
GLYCEROL FORMAL3L7GR2604EIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
aa02f070-0b90-7852-e053-2995a90a7b65a5798b03-3dec-a37c-e053-2995a90a7b122020-07-09WarningsExact identifier
spl set id: a5798b03-3dec-a37c-e053-2995a90a7b12

Reported adverse events (FAERS/openFDA)#

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