FDA.reportPublic FDA data

SEREN GUARD Sanitizing Wipes

Manufacturer
Prime Pace Products LLC
Effective date
2020-12-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:42

Label at a glance#

ProductSEREN GUARD Sanitizing Wipes
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

■ Hand sanitizing to decrease bacteria on the skin. ■ Recommended for hand sanitizing use.

Dosage and administration

■ Thoroughly wipe hands as desired. ■ Allow to dry without wiping. ■ Discard wipe after use. ■ Do not flush.

Storage and handling

■ Keep sealed and store below 95°F (35°C) ■ For External Use Only. Avoid sun exposure and excessive heat above 104°F (40°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ Hand sanitizing to decrease bacteria on the skin.
■ Recommended for hand sanitizing use.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product, avoid contact with the eyes.
In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Discontinue use if irritation and redness develop. If the condition
persists for more than 72 hours, consult a Physician.

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

■ Thoroughly wipe hands as desired.
■ Allow to dry without wiping.
■ Discard wipe after use.
■ Do not flush.

Other Information

STORAGE AND HANDLING SECTION

■ Keep sealed and store below 95°F (35°C)
■ For External Use Only. Avoid sun exposure and excessive heat above 104°F (40°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Aloe Barbadensis Extract,
Phenoxyethanol, Ethylhexylglycerin, Propylene Glycol.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEREN GUARD

Sanitizig Wipes

KILLS 99.9% OF KNOWN GERMS

50
WIPES

Cleansing Formula      Locks in Moisture for Softer Skin

These germ fighting sanitizing wipes kill 99.9% of known germs.
Made with skin friendly ingredients, using no harsh chemicals.

Contains 75% Ethyl Alcohol to kill germs and sanitize hands.
Contains Glycerin to lock in moisture and soften the skin.
Batch No: Printed on bag.

Distributed By: Prime Pace Products LLC, 36181 East Lake Rd, Suite 302, Palm Harbor, FL 34685, USA
Toll Free Number: 866-518-1984
Email: info@primepaceproducts.com

ITEM CODE: SGAL-01
0 0 0 0 2 0 2 0 0 6 0 6 0

Made in China

50 Count

201 50Bag201 50Bag

80 Count

201 80Bag201 80Bag

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79183-201-502023-01-30C16284748780-1f386c649-d8c0-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes
79183-201-802023-01-30C16284748780-1f386c649-d8c0-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79183-201-50SEREN GUARD Sanitizing Wipes50 in 1 BAGPATCH503
79183-201-80SEREN GUARD Sanitizing Wipes80 in 1 BAGPATCH803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79183-201SEREN GUARD SANITIZING WIPES (ETHYL ALCOHOL 75%) PATCH [PRIME PACE PRODUCTS LLC]3Legacy NDC, 2 package rows20201208_a27aed11-514e-492f-ab3a-cbf5fb26d798.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79183-20179183-201-50, 79183-201-80

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
ALOE VERA FLOWER575DY8C1ERIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
0130ea63-d84b-4b8e-9560-582c5ed17b5ca27aed11-514e-492f-ab3a-cbf5fb26d7982020-12-06WarningsExact identifier
spl id: 0130ea63-d84b-4b8e-9560-582c5ed17b5c
spl set id: a27aed11-514e-492f-ab3a-cbf5fb26d798

Reported adverse events (FAERS/openFDA)#

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