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
2
Source
full-release
Hydrated at
2026-05-31 23:34:42

Label at a glance#

ProductSEREN GUARD Sanitizing Wipes
Active ingredientBENZALKONIUM CHLORIDE
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 0-30°C (32-38°F) ■ Avoid sun exposure and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

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 0-30°C (32-38°F)
■ Avoid sun exposure and excessive heat above 40°C (104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Propylene Glycol, Tocophery Acetate,Polysorbate 20 ,
Phenoxyethanol.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80
COUNT

SEREN GUARD

Sanitizig Wipes

STERILIZATION RATE 99.9%

HYGIENIC STERILIZATION FOR HEALTH CARE

Alcohol Free

Skin Friendly Ingredients
Alcohol Free

STORAGE
Store in a cool and dry place.
Avoid direct sunlight.

DIRECTIONS
■Turn the cap counter clockwise to remove and peel off the seal.
■ Gently tug at the center wipe and feed it through the cap from the inside out.
■ Screw the cap back on and you are ready to use. Tilt to remove wipe one at a time.

Skin friendly ingredients.

ITEM CODE : SGNA-05

MATERIAL: NON-WOVEN
WIPES SIZE: 15X20CM
WIPES: 80 SHEET COUNT

Batch No: Printed on side.
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

Made in China

80 Count

Seren80Seren80

160 Count

Seren160Seren160

200 Count

Seren200Seren200

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79183-401-082023-01-30C16284748780-1f386c649-d823-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes
79183-401-162023-01-30C16284748780-1f386c649-d823-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes
79183-401-202023-01-30C16284748780-1f386c649-d823-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79183-401-08SEREN GUARD Sanitizing Wipes80 in 1 BOTTLE, DISPENSINGPATCH802
79183-401-08SEREN GUARD Sanitizing Wipes4.9 g in 1 PATCHPATCH4.92
79183-401-16SEREN GUARD Sanitizing Wipes4.9 g in 1 PATCHPATCH4.92
79183-401-16SEREN GUARD Sanitizing Wipes160 in 1 BOTTLE, DISPENSINGPATCH1602
79183-401-20SEREN GUARD Sanitizing Wipes200 in 1 BOTTLE, DISPENSINGPATCH2002
79183-401-20SEREN GUARD Sanitizing Wipes4.9 g in 1 PATCHPATCH4.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79183-401SEREN GUARD SANITIZING WIPES (SANITIZING WIPES) PATCH [PRIME PACE PRODUCTS LLC]2Legacy NDC, 6 package rows20201208_8595d28d-9870-4045-ad6b-aedefa6c93d6.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
79183-40179183-401-08, 79183-401-16, 79183-401-20

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
83373936-97ff-4ecb-96ac-282a243e0c6f8595d28d-9870-4045-ad6b-aedefa6c93d62020-12-06WarningsExact identifier
spl id: 83373936-97ff-4ecb-96ac-282a243e0c6f
spl set id: 8595d28d-9870-4045-ad6b-aedefa6c93d6

Reported adverse events (FAERS/openFDA)#

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