FDA.reportPublic FDA data

GELRITE

Manufacturer
DERMARITE INDUSTRIES, LLC | DERMARITE INDUSTRIES LLC
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:40:51

Label at a glance#

ProductGELRITE
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

For handwashing to decrease bacteria on skin. Recommended for repeated use.

Dosage and administration

​Wet hands thoroughly with product and allow to dry without wiping. Children under six should be supervised while using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65%

​ Purpose

OTC - PURPOSE SECTION

Skin Protectant

​Uses

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on skin.
  • Recommended for repeated use.

​Warnings

WARNINGS SECTION

For external use only.

​Flammable. Keep away from heat and flame.

Avoid contact with eyes. ​In case of contact, flush thoroughly with water.

Stop use and ask a doctor if skin irritation develops.

.

Directions

DOSAGE & ADMINISTRATION SECTION

  • ​Wet hands thoroughly with product and allow to dry without wiping.
  • Children under six should be supervised while using this product.

Other Information

OTHER SAFETY INFORMATION

  • Do not store above 105°F
  • May discolor some fabrics or surfaces
  • You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

​Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Carbomer, Polysorbate 20, Fragrance, t-Butanol, Triethanolamine, Tocopherol Acetate, Sodium Isostearoyl Lactate, Denatonium Benzoate

Questions?

OTC - QUESTIONS SECTION

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. ​In case of accidental ingestion contact a physician or Poison Control Center right away

GelRite Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN9
902574ethanol 0.65 ML/ML Topical GelSCD9
902574ethyl alcohol 65 % Topical GelSY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61924-106-042026-01-29C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-162026-01-29C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-272026-01-29C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-342026-01-29C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-042024-12-06C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-162024-12-06C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-272024-12-06C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-342024-12-06C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-042024-01-30C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-162024-01-30C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-272024-01-30C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE
61924-106-342024-01-30C16284748780-11030e365-119c-111a-e063-dadaa90a10e2GELRITE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-106-04GELRITE118 mL in 1 BOTTLE, DISPENSINGGEL1189
61924-106-16GELRITE473 mL in 1 BOTTLE, PUMPGEL4739
61924-106-27GELRITE800 mL in 1 BAGGEL8009
61924-106-34GELRITE1000 mL in 1 BAGGEL10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-106GELRITE (HAND SANITIZER) GEL [DERMARITE INDUSTRIES, LLC]9Legacy NDC, 4 package rows20241208_4180193e-9d34-2ecf-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61924-106-04ML - Milliliter61924-106716b6d40-3f1d-454a-b610-6f3d16b084fd12017-11-06
61924-106-16ML - Milliliter61924-10673061636-bee7-4e73-9296-483ad0306cdf12017-11-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61924-10661924-106-04, 61924-106-16, 61924-106-27, 61924-106-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
DENATONIUM BENZOATE ANHYDROUSM5BA6GAF1OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLENE GLYCOL 1,2-DISTEARATET65PN3O37HIACT
BUTANOL (MIXED ISOMERS)WB09NY83YAIACT
2,4,5-T-TROLAMINE9007L1DAXMIACT
SODIUM ISOSTEAROYL LACTYLATE8730J0D3EVIACT

Source Document#

Source XML · Source PDF

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
2888090c-6b34-cf2b-e063-6394a90a64a14180193e-9d34-2ecf-e054-00144ff88e882024-12-05WarningsExact identifier
spl id: 2888090c-6b34-cf2b-e063-6394a90a64a1
spl set id: 4180193e-9d34-2ecf-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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