FDA.reportPublic FDA data

On Guard Sanitizing Gel

Manufacturer
doTERRA International, LLC | Universal Packaging Systems Inc (DBA PakLabs)
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:53:59

Label at a glance#

ProductOn Guard Sanitizing Gel
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Uses • Reduces bacteria on hands[skin] • Recommended for repeated use

Dosage and administration

Directions • Wet hands thoroughly and allow to dry without wiping. • For children under 5, use adult supervision.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose
Ethyl Alcohol 70% v/v ......................... Antiseptic

Antiseptic, Hand Sanitizer

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

Uses
• Reduces bacteria on hands[skin]
• Recommended for repeated use

Warnings

WARNINGS SECTION

Warnings
Flammable. Keep away from flame, spark, or
temperatures above 40°C (104°F)
For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs,
rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop.

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

Directions
• Wet hands thoroughly and allow to dry without wiping.
• For children under 5, use adult supervision.

OTHER SAFETY INFORMATION

Other information
• Store at a temperature below 38°C (100°F)
• Do not use if quality seal is broken

INACTIVE INGREDIENT SECTION

Inactive ingredients Water (Aqua), Eucalyptus Oil, Citrus aurantium
dulcis (Orange) Peel Oil, Hydroxypropyl Guar, Eugenia caryophyllus
(Clove) Bud Oil, Cinnamomum zeylanicum Leaf Oil, Pyrus malus (Apple)
Fruit Extract, Glycerin, Cinnamomum zeylanicum Bark Oil, Eucalyptus
globulus Leaf Oil, Rosmarinus officinalis (Rosemary) Leaf/Stem Oil,
Citric Acid

OTC - QUESTIONS SECTION

Questions? Call 1-800-411-8151

Primary Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PanelPrimary PanelPrimary Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN5
581662ethanol 0.7 ML/ML Topical GelSCD5
581662ethanol 70 % Topical GelSY5
581662ethyl alcohol 70 % Topical GelSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71630-098-50On Guard Sanitizing Gel50 mL in 1 BOTTLEGEL505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71630-098ON GUARD SANITIZING GEL (ALCOHOL) GEL [DOTERRA INTERNATIONAL, LLC]5Current NDC, Legacy NDC, 1 package rows20250130_e4b8b4bb-1d47-6826-e053-2a95a90ab168.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71630-09871630-098-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EUCALYPTUS OIL2R04ONI662IACT
ORANGE OILAKN3KSD11BIACT
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)3A1I7376TCIACT
CLOVE OIL578389D6D0IACT
CINNAMON LEAF OILS92U8SQ71VIACT
GLYCERINPDC6A3C0OXIACT
CINNAMON BARK OILXE54U569ECIACT
HYDRATED SILICAY6O7T4G8P9IACT
BORONN9E3X5056QIACT
ALCOHOL3K9958V90MACTIB
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
ROSEMARY OIL8LGU7VM393IACT

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
On Guard Sanitizing GelALCOHOLdoTERRA International, LLCe4b8b4bb-1d47-6826-e053-2a95a90ab1682025-01-28WarningsExact identifier
ndc (package): 71630-098-50
ndc (product): 71630-098
ndc11 (package): 71630009850
spl id: 2ccc0261-278a-079c-e063-6294a90a7607
spl set id: e4b8b4bb-1d47-6826-e053-2a95a90ab168

Reported adverse events (FAERS/openFDA)#

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