FDA.reportPublic FDA data

SAFEHANDS

Manufacturer
Safehands, LLC
Effective date
2020-09-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:15:41

Label at a glance#

ProductSAFEHANDS
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

To decrease bacteria on the skin

Dosage and administration

Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Do not use 

OTC - DO NOT USE SECTION

in eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if skin irritation develops

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

Directions

DOSAGE & ADMINISTRATION SECTION

Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of this product.

Other Information

SPL UNCLASSIFIED SECTION

Avoid extreme temperatures.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Propylene glycol, Triethylene glycol, Polysorbate-20.

Questions/Comments?

OTC - QUESTIONS SECTION

Call toll free 866-748-9990

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60867-102-032023-02-06C16284748780-1d6a99b39-60cd-a426-e053-dadaa90af4c2SAFEHANDS
60867-102-032022-01-28C16284748780-1d6a99b39-60cd-a426-e053-dadaa90af4c2SAFEHANDS

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
60867-10260867-102-03

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
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRIETHYLENE GLYCOL3P5SU53360IACT
POLYSORBATE 207T1F30V5YHIACT
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
f3bb0261-3bfa-285a-e053-2995a90a5b2b1248638e-e8a1-474d-8ed7-9c1c03c8edce2023-02-02WarningsExact identifier
spl set id: 1248638e-e8a1-474d-8ed7-9c1c03c8edce

Reported adverse events (FAERS/openFDA)#

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