FDA.reportPublic FDA data

SEREN GUARD

Manufacturer
Prime Pace Products LLC
Effective date
2020-12-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:34:41

Label at a glance#

ProductSEREN GUARD
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Storage and handling

Other Information ■ Keep sealed and store between 0-30°C (32 - 86°F) ■ For External Use Only. Avoid sun exposure and excessive heat above 40°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose
Antimicrobial

INDICATIONS & USAGE SECTION

Uses ■ Hand Sanitizer to decrease bacteria on skin.

        ■ Recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only.

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 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.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Other Information

■ Keep sealed and store between 0-30°C (32 - 86°F)
■ For External Use Only. Avoid sun exposure and excessive heat above 40°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Aqua, Propylene Glycol, Tocopheryl Acetate, Polysorbate 20,
Phenoxyethanol.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEREN GUARD                                           80
                                                              WIPES     

Alcohol Free                        Skin friendly Ingredients

SEREN GUARD                           80
                            WIPES

Sanitizing Wipes
STERILIZATION RATE 99.9%

USAGE
Click open the lid and peel back the resealable label.
Pull a sterilized wipe for sanitizing hands.
Reseal label after use to prevent the wipes from drying.

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: SGNA-02

6  970366 697128

Made in China

80 Wipes

SEREN 80SEREN 80

50 Wipes

SEREN 50SEREN 50

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79183-001-502023-01-30C16284748780-1f386c649-c503-0266-e053-dadaa90a7c1a4ff8256f-876f-40fb-964c-df15c055deaf
79183-001-802023-01-30C16284748780-1f386c649-c503-0266-e053-dadaa90a7c1a4ff8256f-876f-40fb-964c-df15c055deaf

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79183-001SEREN GUARD (SANITIZING WIPES) PATCH [PRIME PACE PRODUCTS LLC]4Legacy NDC20201208_4ff8256f-876f-40fb-964c-df15c055deaf.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
79183-00179183-001-80, 79183-001-50

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
60e30d46-675b-4be1-a628-94cbabd0742f4ff8256f-876f-40fb-964c-df15c055deaf2020-12-06WarningsExact identifier
spl id: 60e30d46-675b-4be1-a628-94cbabd0742f
spl set id: 4ff8256f-876f-40fb-964c-df15c055deaf

Reported adverse events (FAERS/openFDA)#

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