FDA.reportPublic FDA data

Safe - X

Manufacturer
Green Smart Plastics LLC
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:18

Label at a glance#

ProductSafe - X
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive IngredientActive Ingredient

OTC - ASK DOCTOR SECTION

ask Doctorask DoctorAsk Doctor section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

ChildrenChildrenKeep out childern

INACTIVE INGREDIENT SECTION

inactiveinactiveInactive Ingredien

WARNINGS SECTION

WarningWarningWarnign Section

INDICATIONS & USAGE SECTION

Usage & IndicationUsage & IndicationIndication Usage

DOSAGE FORMS & STRENGTHS SECTION

DosageDosageDosage

DOSAGE & ADMINISTRATION SECTION

Dosage & adminDosage & adminDosage & Admin

OTC - PURPOSE SECTION

purpose - oTCpurpose - oTCPurpose section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackagePackage label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77164-618-012022-01-28C16284748780-1d6a99b39-a91a-a426-e053-dadaa90af4c2a85d2182-a01e-bb53-e053-2a95a90a4f1d
77164-618-042022-01-28C16284748780-1d6a99b39-a91a-a426-e053-dadaa90af4c2a85d2182-a01e-bb53-e053-2a95a90a4f1d
77164-618-162022-01-28C16284748780-1d6a99b39-a91a-a426-e053-dadaa90af4c2a85d2182-a01e-bb53-e053-2a95a90a4f1d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77164-618-01Safe - X3785 mL in 1 JUGLIQUID37851
77164-618-04Safe - X29 mL in 1 BOTTLE, PUMPLIQUID291
77164-618-16Safe - X473 mL in 1 BOTTLE, PUMPLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77164-618SAFE - X (BENZALKONIUM CHLORIDE 0.1%) LIQUID [GREEN SMART PLASTICS LLC]1Legacy NDC, 3 package rows20200619_a85d2182-a01e-bb53-e053-2a95a90a4f1d.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77164-61877164-618-01, 77164-618-04, 77164-618-16

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
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
GLYCERETH-17 COCOATE3057VPT0KCIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT

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
a85d2182-a01f-bb53-e053-2a95a90a4f1da85d2182-a01e-bb53-e053-2a95a90a4f1d2020-06-18WarningsExact identifier
spl id: a85d2182-a01f-bb53-e053-2a95a90a4f1d
spl set id: a85d2182-a01e-bb53-e053-2a95a90a4f1d

Reported adverse events (FAERS/openFDA)#

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