FDA.reportPublic FDA data

DermaGel Clear Hand Sanitizing Gel

Manufacturer
Inopak. Ltd
Effective date
2022-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:03

Label at a glance#

ProductDermaGel
Active ingredientALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Alcohol 70% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment
  • recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only

Flammable. Keep away from heat or flame.

OTC - WHEN USING SECTION

When using this product keep away from eyes. In case of eye contact, flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply liberally to hands to cover all surfaces
  • rub hands together until dry
  • supervise children under 6 years old
  • not recommended for infants

INACTIVE INGREDIENT SECTION

Ingredients Water, Glycerin, Propylene Glycol, Isopropy Myristate, Aloe Barbedensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Carbomer, Triisopropanolamine

SPL UNCLASSIFIED SECTION

Manufactured for Inopak, LTD., Ringwood, NJ 07456

1-800-762-7725 • www.inopak.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermaGel®

HAND SANITIZING GEL with moisturizers

70% Alcohol with ALOE VERA & VITAMIN E

KILLS 99.99% OF GERMS!

NET CONTENTS: 800 ML (27 FL. OZ.)

58575-231 DermaGel 062258575-231 DermaGel 0622

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58575-231-802024-01-30C16284748780-11030e365-5439-111a-e063-dadaa90a10e2DermaGel Clear Hand Sanitizing Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58575-231-80DermaGel800 mL in 1 POUCHGEL8001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58575-231DERMAGEL (ALCOHOL) GEL [INOPAK. LTD]1Legacy NDC, 1 package rows20220702_e29b7c78-54f6-e6d5-e053-2a95a90a9b23.zip

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
58575-23158575-231-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
WATER059QF0KO0RIACT
TRIISOPROPANOLAMINEW9EN9DLM98IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALCOHOL3K9958V90MACTIB
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
e29b7c78-54f8-e6d5-e053-2a95a90a9b23e29b7c78-54f6-e6d5-e053-2a95a90a9b232022-06-29WarningsExact identifier
spl id: e29b7c78-54f8-e6d5-e053-2a95a90a9b23
spl set id: e29b7c78-54f6-e6d5-e053-2a95a90a9b23

Reported adverse events (FAERS/openFDA)#

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