FDA.reportPublic FDA data

True San Foaming Hand Sanitizer

Manufacturer
Pure and Gentle Inc
Effective date
2021-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:53:52

Label at a glance#

ProductTrue San Foaming Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Hand sanitizer to remove microorganisms on the skin Use this product when soap and water are not available.

Dosage and administration

Dispense 1 pump of products onto palm of hand and rub thoroughly over all surfaces of both hands until dry. Read the entire label before using this product.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to remove microorganisms on the skin
  • Use this product when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develop and persist for more than 72 hours.

Do not use on children under 6 years old.

OTC - DO NOT USE SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dispense 1 pump of products onto palm of hand and rub thoroughly over all surfaces of both hands until dry.
  • Read the entire label before using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Laurtrimonium Chloride, Cetrimonium Chloride, Dihydroxyethyl cocamine Oxide, Propylene Glycol

Questions or Comments?

OTC - QUESTIONS SECTION

(800) 876-9455.

Package Labeling:100ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78171-00278171-002-01, 78171-002-02

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
WATER059QF0KO0RIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
ce2a3e72-9b2e-f5d0-e053-2995a90a3c80ba0d81fe-1e6d-2c64-e053-2995a90a219b2021-10-12WarningsExact identifier
spl set id: ba0d81fe-1e6d-2c64-e053-2995a90a219b

Reported adverse events (FAERS/openFDA)#

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