FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Noble Roots, LLC | Pharmco Laboratories, Inc.
Effective date
2020-06-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:34

Label at a glance#

ProductHand Sanitizer
Active ingredientAlcohol
Label structure11 sections

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 43°C (100°F) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age
  • on open skin wounds

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.

OTC - STOP USE SECTION

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or call a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 43°C (100°F)
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Hydroxide

Questions?

OTC - QUESTIONS SECTION

678-897-4758

SPL UNCLASSIFIED SECTION

Distributed by:
Noble Roots LLC
Lawrenceville, GA 30043

PRINCIPAL DISPLAY PANEL - 228 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

noble
roots®

Hand
Sanitizer
Infused with
Moisturizing
Aloe Vera

8 oz (228 mL)

PRINCIPAL DISPLAY PANEL - 228 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 228 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76577-010-082022-01-28C16284748780-1d6a99b39-4052-a426-e053-dadaa90af4c2Hand Sanitizer
76577-010-802022-01-28C16284748780-1d6a99b39-4052-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76577-010-08Hand Sanitizer228 mL in 1 BOTTLE, PLASTICGEL2282
76577-010-80Hand Sanitizer3790 mL in 1 BOTTLE, PLASTICGEL37902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76577-010HAND SANITIZER (ALCOHOL) GEL [NOBLE ROOTS, LLC]2Legacy NDC, 2 package rows20200613_fd0621f3-6919-416d-99ec-5b726fcb0b9b.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76577-01076577-010-08, 76577-010-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Hydroxyethyl Cellulose, UnspecifiedT4V6TWG28DIACT
Aloe Vera LeafZY81Z83H0XIACT
Citric Acid Monohydrate2968PHW8QPIACT
Sodium Hydroxide55X04QC32IIACT

Source Document#

Source XML · Source PDF

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
32691a63-78c6-4447-95cc-346198fc62d0fd0621f3-6919-416d-99ec-5b726fcb0b9b2020-06-12WarningsExact identifier
spl id: 32691a63-78c6-4447-95cc-346198fc62d0
spl set id: fd0621f3-6919-416d-99ec-5b726fcb0b9b

Reported adverse events (FAERS/openFDA)#

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