FDA.reportPublic FDA data

Insta San

Manufacturer
Anderson Chemical Company
Effective date
2020-06-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:53

Label at a glance#

ProductInsta San
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

▪ Pump a small amount of foam into palm of hand ▪ Rub thoroughly over all surfaces of both hands ▪ Rub hands together briskly until dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chlorinde, 0.1% w/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on skin.
  • Recommended for repeated use.

Warning

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contat, flush eyes with water.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation or redness develops, or if conditions perist for more that 72 hours.

Keep out of reach of children

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

▪ Pump a small amount of foam into palm of hand

▪ Rub thoroughly over all surfaces of both hands

▪ Rub hands together briskly until dry

INACTIVE INGREDIENT SECTION

Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

Questions

OTC - QUESTIONS SECTION

Question or comments? 320-693-2477

First Aid

OTHER SAFETY INFORMATION

Eye contact: Flush immediately with plenty of water for 15 minutes. Lift upper and lower eyelids for
complete rinsing. If irritation persists after rinsing, get medical attention.
Skin Contact: If irritation occurs, discontinue use. If irritation persists, call a physician.
Ingestion: Drink 1 or 2 glasses of water. Call a physician.

Directions

RECENT MAJOR CHANGES SECTION

▪ Pump a small amount of foam into palm of hand

▪ Rub thoroughly over all surfaces of both hands

▪ Rub hands together briskly until dry

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jug LabelJug Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN2
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD2
1038799benzalkonium chloride 0.1 % Topical FoamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63131-1134-12022-01-28C16284748780-1d6a99b39-5b7d-a426-e053-dadaa90af4c2a45cf83f-ec32-643d-e053-2a95a90ad8a6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63131-1134-1Insta San7570 in 1 CASELIQUID75702
63131-1134-1Insta San3785 mL in 1 JUGLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63131-1134INSTA SAN (BENZALKONIUM CHLORIDE) LIQUID [ANDERSON CHEMICAL COMPANY]2Legacy NDC, 2 package rows20200625_a45cf83f-ec32-643d-e053-2a95a90ad8a6.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63131-113463131-1134-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
.BETA.-CITRONELLOL, (+/-)-565OK72VNFIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
WATER059QF0KO0RIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CITRALT7EU0O9VPPIACT
LINALOOL, (+/-)-D81QY6I88EIACT

Source Document#

Source XML · Source PDF

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
a8d98511-f38f-76c3-e053-2a95a90a9bd3a45cf83f-ec32-643d-e053-2a95a90ad8a62020-06-24WarningsExact identifier
spl id: a8d98511-f38f-76c3-e053-2a95a90a9bd3
spl set id: a45cf83f-ec32-643d-e053-2a95a90ad8a6

Reported adverse events (FAERS/openFDA)#

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