FDA.reportPublic FDA data

GuardRx Unscented

Manufacturer
GPS Associates | GPS Associates, LLC
Effective date
2020-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:48

Label at a glance#

ProductGuardRx Red Thyme
Active ingredientALCOHOL
Label structure29 sections

Indications and uses

-For hand washing to decrease bacteria on skin. -Recommended for repeated use.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. -Do not use other than directed.

Storage and handling

Store at room temperature 20-25 °C (66-77 °F)

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Ethanol 62%

Uses:

INDICATIONS & USAGE SECTION

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

WARNINGS SECTION

-Flammable, keep away from children.

OTC - WHEN USING SECTION

-For external use only.

OTC - DO NOT USE SECTION

-Do not use in eyes. If contact occurs, flush thoroughly with water.

OTC - ASK DOCTOR SECTION

-Stop use and ask a doctor if redness and irritation develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

-Keep our of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

-Do not use other than directed.

STORAGE AND HANDLING SECTION

Store at room temperature 20-25 °C (66-77 °F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Citrus Aurantium Dulcis (Orange) Peel Oil, Thymus Vulgaris (Red Thyme) Oil, Tocopherol.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Ethanol 62%

Purpose:

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

WARNINGS SECTION

-Flammable, keep away from children.

OTC - WHEN USING SECTION

-For external use only.

OTC - DO NOT USE SECTION

-Do not use in eyes. If contact occurs, flush thoroughly with water.

OTC - ASK DOCTOR SECTION

-Stop use and ask a doctor if redness and irritation develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

-Keep our of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

-Do not use other than directed.

STORAGE AND HANDLING SECTION

Store at room temperature 20-25 °C (66-77 °F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Tocopherol.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Ethanol 62%

Purpose:

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

WARNINGS SECTION

-Flammable, keep away from children.

OTC - WHEN USING SECTION

-For external use only.

OTC - DO NOT USE SECTION

-Do not use in eyes. If contact occurs, flush thoroughly with water.

OTC - ASK DOCTOR SECTION

-Stop use and ask a doctor if redness and irritation develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

-Keep our of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

-Do not use other than directed.

STORAGE AND HANDLING SECTION

Store at room temperature 20-25 °C (66-77 °F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Tocopherol.

59 mL NDC: 74306-123-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

red thyme 59 ml labelred thyme 59 ml label

118 mL NDC: 74306-123-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 ml label118 ml label

236 mL NDC: 74306-123-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 ml label236 ml label

59 mL NDC: 74306-124-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 ml label59 ml label

118 mL NDC: 74306-124-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 ml label118 ml label

236 mL NDC: 74306-124-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 ml label236 ml label

59 mL NDC: 74306-125-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 ml label59 ml label

118 mL NDC: 74306-125-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 ml label118 ml label

236 mL NDC: 74306-125-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 ml label236 ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN1
247835ethanol 0.62 ML/ML Topical SolutionSCD1
247835ethanol 62 % Topical SolutionSY1
247835ethyl alcohol 62 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74306-123-022021-07-23C16284748780-1c7ccaba7-2571-fd44-e053-dadaa90aa01bGuard Rx Hand Sanitizer Red Thyme Oil
74306-123-042021-07-23C16284748780-1c7ccaba7-2571-fd44-e053-dadaa90aa01bGuard Rx Hand Sanitizer Red Thyme Oil
74306-123-082021-07-23C16284748780-1c7ccaba7-2571-fd44-e053-dadaa90aa01bGuard Rx Hand Sanitizer Red Thyme Oil
74306-124-022021-07-23C16284748780-1c7ccaba7-2571-fd44-e053-dadaa90aa01bGuard Rx Hand Sanitizer Red Thyme Oil
74306-124-042021-07-23C16284748780-1c7ccaba7-2571-fd44-e053-dadaa90aa01bGuard Rx Hand Sanitizer Red Thyme Oil
74306-124-082021-07-23C16284748780-1c7ccaba7-2571-fd44-e053-dadaa90aa01bGuard Rx Hand Sanitizer Red Thyme Oil
74306-125-022021-07-23C16284748780-1c7ccaba7-2571-fd44-e053-dadaa90aa01bGuard Rx Hand Sanitizer Red Thyme Oil
74306-125-042021-07-23C16284748780-1c7ccaba7-2571-fd44-e053-dadaa90aa01bGuard Rx Hand Sanitizer Red Thyme Oil
74306-125-082021-07-23C16284748780-1c7ccaba7-2571-fd44-e053-dadaa90aa01bGuard Rx Hand Sanitizer Red Thyme Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74306-123-02GuardRx Red Thyme59 mL in 1 BOTTLE, SPRAYLIQUID591
74306-123-04GuardRx Red Thyme118 mL in 1 BOTTLE, SPRAYLIQUID1181
74306-123-08GuardRx Red Thyme236 mL in 1 BOTTLE, SPRAYLIQUID2361
74306-124-02GuardRx Lavender Peppermint59 mL in 1 BOTTLE, SPRAYLIQUID591
74306-124-04GuardRx Lavender Peppermint118 mL in 1 BOTTLE, SPRAYLIQUID1181
74306-124-08GuardRx Lavender Peppermint236 mL in 1 BOTTLE, SPRAYLIQUID2361
74306-125-02GuardRx Unscented59 mL in 1 BOTTLE, SPRAYLIQUID591
74306-125-04GuardRx Unscented118 mL in 1 BOTTLE, SPRAYLIQUID1181
74306-125-08GuardRx Unscented236 mL in 1 BOTTLE, SPRAYLIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74306-123GUARDRX RED THYME (HAND SANITIZER) LIQUID GUARDRX LAVENDER PEPPERMINT (HAND SANITIZER) LIQUID GUARDRX UNSCENTED (HAND SANITIZER) LIQUID [GPS ASSOCIATES]1Legacy NDC, 3 package rows20200403_a1cb21f4-f3f9-365f-e053-2a95a90a23f4.zip
74306-124GUARDRX RED THYME (HAND SANITIZER) LIQUID GUARDRX LAVENDER PEPPERMINT (HAND SANITIZER) LIQUID GUARDRX UNSCENTED (HAND SANITIZER) LIQUID [GPS ASSOCIATES]1Legacy NDC, 3 package rows20200403_a1cb21f4-f3f9-365f-e053-2a95a90a23f4.zip
74306-125GUARDRX RED THYME (HAND SANITIZER) LIQUID GUARDRX LAVENDER PEPPERMINT (HAND SANITIZER) LIQUID GUARDRX UNSCENTED (HAND SANITIZER) LIQUID [GPS ASSOCIATES]1Legacy NDC, 3 package rows20200403_a1cb21f4-f3f9-365f-e053-2a95a90a23f4.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74306-12374306-123-02, 74306-123-04, 74306-123-08
74306-12474306-124-02, 74306-124-04, 74306-124-08
74306-12574306-125-02, 74306-125-04, 74306-125-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ORANGE OILAKN3KSD11BIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
THYME OIL2UK410MY6BIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
PEPPERMINT OILAV092KU4JHIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
LAVENDER OILZBP1YXW0H8IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT

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
a1cb21f4-f3fa-365f-e053-2a95a90a23f4a1cb21f4-f3f9-365f-e053-2a95a90a23f42020-03-26WarningsExact identifier
spl id: a1cb21f4-f3fa-365f-e053-2a95a90a23f4
spl set id: a1cb21f4-f3f9-365f-e053-2a95a90a23f4

Reported adverse events (FAERS/openFDA)#

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