FDA.reportPublic FDA data

Promedic

Manufacturer
Perfect Medics, Inc
Effective date
2020-09-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:29:29

Label at a glance#

ProductPromedic
Active ingredientBenzalkonium chloride
Label structure9 sections

Indications and uses

to decrease bacteria on the skin that could cause disease.

Dosage and administration

Wipe down surface thoroughly and allow to air-dry. For children under 6, use only under adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Warnings

WARNINGS SECTION


For external use only.

When using the product

  • Keep out of eyes, in case of contact with eyes, flush thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest

Stop use and ask a doctor if skin irritation develops.

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin that could cause disease.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wipe down surface thoroughly and allow to air-dry.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a poison control center right away.

Other Information

SPL UNCLASSIFIED SECTION

  • do not store above 105F.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, glycerin, phenoxyethanol, polysorbate 20 (Polyoxyethylene (20) sorbitan monolaurate), aloe vera leaf juice.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79134-001-012022-01-28C16284748780-1d6a99b39-7b51-a426-e053-dadaa90af4c2Promedic DISINFECTING WIPES
79134-001-022022-01-28C16284748780-1d6a99b39-7b51-a426-e053-dadaa90af4c2Promedic DISINFECTING WIPES
79134-001-032022-01-28C16284748780-1d6a99b39-7b51-a426-e053-dadaa90af4c2Promedic DISINFECTING WIPES
79134-001-042022-01-28C16284748780-1d6a99b39-7b51-a426-e053-dadaa90af4c2Promedic DISINFECTING WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79134-001-01Promedic450 mL in 1 PACKETCLOTH4503
79134-001-01Promedic80 in 1 BOXCLOTH803
79134-001-02Promedic467 mL in 1 PACKETCLOTH4673
79134-001-02Promedic80 in 1 CANISTERCLOTH803
79134-001-03Promedic10 in 1 CANISTERCLOTH103
79134-001-03Promedic60 mL in 1 PACKETCLOTH603
79134-001-04Promedic80 in 1 CANISTERCLOTH803
79134-001-04Promedic450 mL in 1 PACKETCLOTH4503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79134-001PROMEDIC (BENZALKONIUM CHLORIDE) CLOTH [PERFECT MEDICS, INC]3Legacy NDC, 8 package rows20200917_10796529-26d2-4e67-b18c-8ef73203ba3d.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
79134-00179134-001-01, 79134-001-02, 79134-001-03, 79134-001-04

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
Benzalkonium chlorideF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
ALOE VERA LEAFZY81Z83H0XIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT

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
27dd463b-bf63-4591-87d1-f815a28da79610796529-26d2-4e67-b18c-8ef73203ba3d2020-09-16WarningsExact identifier
spl id: 27dd463b-bf63-4591-87d1-f815a28da796
spl set id: 10796529-26d2-4e67-b18c-8ef73203ba3d

Reported adverse events (FAERS/openFDA)#

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