FDA.reportPublic FDA data

SAFMAXX Hand Sanitizer

Manufacturer
G&N Enterprise,LLC
Effective date
2020-11-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:33:50

Label at a glance#

ProductSAFMAXX Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Storage and handling

Other information store in a cool, dry place below 104 o F (40 o C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • handwash to help reduce bacteria that potentially can cause disease
  • helps to prevent cross-contamination by hand contact
  • helps to prevent drying of the skin
  • recommended for repeated use

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply appropriate amount of product into palm of hand
  • rub thouroughtly over all surfaces of both hands for at least 20 seconds
  • rub hands together until dry

STORAGE AND HANDLING SECTION

Other information

store in a cool, dry place below 104 o F (40 o C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, cocamidopropyl betaine, glycerine, polozamer 124, benzyl alcohol, phenoxyethanol,FD&C Blue No.1

OTC - QUESTIONS SECTION

Questions?

Contact G&N Enterprise, LLC at 800-290-6816 Mon-Fri 9 am-5 pm CST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFMAXX_250SAFMAXX_250

SAFMAXX_45MLSAFMAXX_45ML

SAFMAXX

Hand Sanitizer

Non_Alcohol

Microbiological Shield

Made in the USA

Benzalkonium Chloride 0.13%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN3
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD3
1020365benzalkonium chloride 0.13 % Topical FoamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69731-041-202022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer
69731-041-212022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer
69731-041-222022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer
69731-041-232022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer
69731-041-242022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer
69731-041-252022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer
69731-041-262022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer
69731-041-272022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer
69731-041-282022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer
69731-041-292022-01-28C16284748780-1d6a99b39-6564-a426-e053-dadaa90af4c2SAFMAXX Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69731-041-20SAFMAXX Hand Sanitizer45 mL in 1 BOTTLELIQUID453
69731-041-21SAFMAXX Hand Sanitizer946352 mL in 1 TANKLIQUID9463523
69731-041-22SAFMAXX Hand Sanitizer208197 mL in 1 DRUMLIQUID2081973
69731-041-23SAFMAXX Hand Sanitizer3785 mL in 1 JUGLIQUID37853
69731-041-24SAFMAXX Hand Sanitizer60 mL in 1 BOTTLELIQUID603
69731-041-25SAFMAXX Hand Sanitizer1000 mL in 1 BOTTLELIQUID10003
69731-041-26SAFMAXX Hand Sanitizer1893 mL in 1 BOTTLELIQUID18933
69731-041-27SAFMAXX Hand Sanitizer500 mL in 1 BOTTLELIQUID5003
69731-041-28SAFMAXX Hand Sanitizer250 mL in 1 BOTTLELIQUID2503
69731-041-29SAFMAXX Hand Sanitizer20 mL in 1 BOTTLELIQUID203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69731-041SAFMAXX HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [G&N ENTERPRISE,LLC]3Legacy NDC, 10 package rows20201118_aabfc18e-f6dd-de28-e053-2a95a90aeae0.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
69731-04169731-041-21, 69731-041-22, 69731-041-23, 69731-041-25, 69731-041-28, 69731-041-20, 69731-041-29, 69731-041-27, 69731-041-24, 69731-041-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 1241S66E28KXAIACT
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
b457acdc-68fa-8da6-e053-2995a90a0119aabfc18e-f6dd-de28-e053-2a95a90aeae02020-11-17WarningsExact identifier
spl id: b457acdc-68fa-8da6-e053-2995a90a0119
spl set id: aabfc18e-f6dd-de28-e053-2a95a90aeae0

Reported adverse events (FAERS/openFDA)#

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