FDA.reportPublic FDA data

Chemstation Hand Sanitizing Gel

Manufacturer
CHEMSTATION SOUTHERN CALIFORNIA, INC.
Effective date
2020-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:29

Label at a glance#

ProductChemstation Hand Sanitizing Gel
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

  • in 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.

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

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified water USP, glycerin, carbomer, hydrogen peroxide.

Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80291-003-012022-01-28C16284748780-1d6a99b39-6117-a426-e053-dadaa90af4c2Chemstation Hand Sanitizing Gel
80291-003-022022-01-28C16284748780-1d6a99b39-6117-a426-e053-dadaa90af4c2Chemstation Hand Sanitizing Gel
80291-003-032022-01-28C16284748780-1d6a99b39-6117-a426-e053-dadaa90af4c2Chemstation Hand Sanitizing Gel
80291-003-042022-01-28C16284748780-1d6a99b39-6117-a426-e053-dadaa90af4c2Chemstation Hand Sanitizing Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80291-003-01Chemstation Hand Sanitizing Gel236 mL in 1 BOTTLEGEL2361
80291-003-02Chemstation Hand Sanitizing Gel473 mL in 1 BOTTLEGEL4731
80291-003-03Chemstation Hand Sanitizing Gel946 mL in 1 BOTTLEGEL9461
80291-003-04Chemstation Hand Sanitizing Gel3.785 mL in 1 BOTTLEGEL3.7851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80291-003CHEMSTATION HAND SANITIZING GEL (ALCOHOL) GEL [CHEMSTATION SOUTHERN CALIFORNIA, INC.]1Legacy NDC, 4 package rows20200917_22aa4a8f-a261-4289-bfde-316b4b059226.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
80291-00380291-003-01, 80291-003-02, 80291-003-03, 80291-003-04

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
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

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
0d59f3e3-0ce2-4eb4-bba8-891397efcfd822aa4a8f-a261-4289-bfde-316b4b0592262020-09-03WarningsExact identifier
spl id: 0d59f3e3-0ce2-4eb4-bba8-891397efcfd8
spl set id: 22aa4a8f-a261-4289-bfde-316b4b059226

Reported adverse events (FAERS/openFDA)#

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