FDA.reportPublic FDA data

pearls Antiseptic Wet Wipes Pine

Manufacturer
Premier Brands Usa Llc
Effective date
2020-09-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:29:23

Label at a glance#

Productpearls Antiseptic Wet Wipes Pine
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

wet wipes to decrease bacteria on the skin  recommended for repeated use  for use when soap and water are not available

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping discard wipe in trash receptacle after use supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C (104°F) may discolour certain fabric or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.38%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • wet wipes to decrease bacteria on the skin
  •  recommended for repeated use
  •  for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame

For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds
  •  if you are allergic to any of the ingredients

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water for 15-20 minutes. Remove contact lenses, if present.

Stop use and ask a doctor if

  • irritation and redness developlop
  • condition persists for more than 72 hours

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

  • wet hands thoroughly with product and allow to dry without wiping
  • discard wipe in trash receptacle after use
  • supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)
  • may discolour certain fabric or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, peg 7glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, phenoxyethanol, dehydroaceer, peg 7glyceryl cocoate,
polysorbate 20, cocamidopropyl betaine, phenoxyethanol, dehydroacetic acid, benzoic acid, fragrance, edetate sodium, citric acid

Questions?

OTC - QUESTIONS SECTION

+1-954-993-9149
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

PURE FRESH, PERFUMIC, ULTRA SOFT, TRUSTED

ANTIBACTERIAL PROTECTION

ALCOHOL FREE

NEUTRAL pH 5,5

Clean your Hand 

KEEP YOUR FAMILY HYGIENICALLY CLEAN

Fresh Pearls Wipes are the quick and easy way. Keep your family hygienically clean and protected at home away. They are ideal for instant clean ups of hands or face. Keep hands clean whether you are at home or in travelling.
Convenient for us in healthcare, nursing stations, patient bedside, long-term nursing care, the home, offices, car, restaurants, health clubs, workshops ... whenever soap and water are not available

Distributed By:

PREMIER BRANDS USA LLC

Pompano Beach, FL 33060

MADE IN TURKEY

DRY PLACE AWAY FROM DIRECT SUNLIGHT

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2390357benzalkonium chloride 0.38 % Medicated PadPSN5
2390357benzalkonium chloride 3.8 MG/ML Medicated PadSCD5
2390357benzalkonium chloride 0.38 % Medicated PadSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79361-101-082022-07-29C16284748780-1e4f33bdf-a428-d8a0-e053-dadaa90a6e4eFresh perfumed pearls ® Antiseptic wet Wipes Pine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79361-101-08pearls Antiseptic Wet Wipes Pine80 in 1 PACKETPATCH805
79361-101-08pearls Antiseptic Wet Wipes Pine4.59 g in 1 PATCHPATCH4.595

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79361-101PEARLS ANTISEPTIC WET WIPES PINE (BENZALKONIUM CHLORIDE) PATCH [PREMIER BRANDS USA LLC]5Legacy NDC, 2 package rows20200916_56e9d344-4540-4109-9c2e-e8013fd613d0.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
79361-10179361-101-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
POLYSORBATE 207T1F30V5YHIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DEHYDROACETIC ACID2KAG279R6RIACT
BENZOIC ACID8SKN0B0MIMIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
3b8c6e33-d3c3-458a-83b4-d07f7da0470b56e9d344-4540-4109-9c2e-e8013fd613d02020-09-15WarningsExact identifier
spl id: 3b8c6e33-d3c3-458a-83b4-d07f7da0470b
spl set id: 56e9d344-4540-4109-9c2e-e8013fd613d0

Reported adverse events (FAERS/openFDA)#

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