FDA.reportPublic FDA data

STERN-X HAND SANITIZER

Manufacturer
United Sierra Group Corp
Effective date
2021-04-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:29

Label at a glance#

ProductSTERN-X HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

Health care personnel hand rub to help reduce bacteria that potentially can cause disease. Hand Sanitizer to help reduce bacteria on the skin if soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • on children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Glycerin, Hydrogen Peroxide, Fragrance, Yellow 5 (CI 19140), Blue 1 (CI 42090)

SPL UNCLASSIFIED SECTION

Soothing & Moisturizing Liquid

KILLS 99.9% OF MOST GERMS*

Packed & Distributed by:
UNITED SIERRA GROUP CORP.
Miami, FL 33016

www.stern-x.com
Questions & Comments:1-800-255-3924

Made in USA

*Effective at eliminating more than 99.9% of many common harmful germs and bacteria in as little as 15 seconds.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN2
1047755ethanol 0.75 ML/ML Topical SolutionSCD2
1047755ethanol 75 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79087-401-112022-07-29C16284748780-1e4f33bdf-9f44-d8a0-e053-dadaa90a6e4eSTERN-X™ HAND SANITIZER
79087-401-122022-07-29C16284748780-1e4f33bdf-9f44-d8a0-e053-dadaa90a6e4eSTERN-X™ HAND SANITIZER
79087-401-142022-07-29C16284748780-1e4f33bdf-9f44-d8a0-e053-dadaa90a6e4eSTERN-X™ HAND SANITIZER
79087-401-152022-07-29C16284748780-1e4f33bdf-9f44-d8a0-e053-dadaa90a6e4eSTERN-X™ HAND SANITIZER
79087-401-162022-07-29C16284748780-1e4f33bdf-9f44-d8a0-e053-dadaa90a6e4eSTERN-X™ HAND SANITIZER
79087-401-172022-07-29C16284748780-1e4f33bdf-9f44-d8a0-e053-dadaa90a6e4eSTERN-X™ HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79087-401-11STERN-X HAND SANITIZER236 mL in 1 BOTTLELIQUID2362
79087-401-12STERN-X HAND SANITIZER473 mL in 1 BOTTLELIQUID4732
79087-401-14STERN-X HAND SANITIZER1893 mL in 1 BOTTLELIQUID18932
79087-401-15STERN-X HAND SANITIZER3785 mL in 1 BOTTLELIQUID37852
79087-401-16STERN-X HAND SANITIZER74 mL in 1 BOTTLELIQUID742
79087-401-17STERN-X HAND SANITIZER120 mL in 1 BOTTLELIQUID1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79087-401STERN-X HAND SANITIZER (ALCOHOL) LIQUID [UNITED SIERRA GROUP CORP]2Legacy NDC, 6 package rows20210406_e2f6510e-6c80-4335-bfa4-a5dae04c0e40.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79087-40179087-401-16, 79087-401-17, 79087-401-11, 79087-401-12, 79087-401-14, 79087-401-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
b13867f9-23d4-4a54-8538-f38a890e60fce2f6510e-6c80-4335-bfa4-a5dae04c0e402021-04-01WarningsExact identifier
spl id: b13867f9-23d4-4a54-8538-f38a890e60fc
spl set id: e2f6510e-6c80-4335-bfa4-a5dae04c0e40

Reported adverse events (FAERS/openFDA)#

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