FDA.reportPublic FDA data

ADCLEAN Medical Gel

Manufacturer
Adfast Corp | Dan Garnett
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:50

Label at a glance#

ProductADCLEAN Medical Gel
Active ingredientISOPROPYL ALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Purified water = 26.25 v%
  3. Rapidgel EZ1 = 3.00 v%
  4. Hydrogen peroxide 29% = 0.45 v%
  5. Fragrance = 0.30 v%

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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

Water

Polyethylene Glycol

Acrylate Polymer

Hydrogen Peroxide

Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

78335-002

10L Medical Gel10L Medical Gel

470ml Medical Gel470ml Medical Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN2
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD2
581698isopropyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78335-002-012023-07-28C16284748780-1d6a99b39-7781-a426-e053-dadaa90af4c2ADCLEAN Medical Gel
78335-002-022023-07-28C16284748780-1d6a99b39-7781-a426-e053-dadaa90af4c2ADCLEAN Medical Gel
78335-002-012022-01-31C16284748780-1d6a99b39-7781-a426-e053-dadaa90af4c2ADCLEAN Medical Gel
78335-002-022022-01-31C16284748780-1d6a99b39-7781-a426-e053-dadaa90af4c2ADCLEAN Medical Gel
78335-002-012022-01-28C16284748780-1d6a99b39-7781-a426-e053-dadaa90af4c2ADCLEAN Medical Gel
78335-002-022022-01-28C16284748780-1d6a99b39-7781-a426-e053-dadaa90af4c2ADCLEAN Medical Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78335-002-01ADCLEAN Medical Gel10000 mL in 1 JUGGEL100002
78335-002-02ADCLEAN Medical Gel470 mL in 1 BOTTLE, DISPENSINGGEL4702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78335-002ADCLEAN MEDICAL GEL (ISOPROPYL ALCOHOL) GEL [ADFAST CORP]2Legacy NDC, 2 package rows20220201_aa918b1f-8e7f-10d3-e053-2995a90a8e77.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
78335-00278335-002-01, 78335-002-02

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
RAPIDGEL EZ133JH4A7R2KIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
FRAGRANCE LEMON ORC2001060K1725A7G95IACT

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
d6701eaf-3f18-6cd4-e053-2a95a90af21caa918b1f-8e7f-10d3-e053-2995a90a8e772022-01-25WarningsExact identifier
spl id: d6701eaf-3f18-6cd4-e053-2a95a90af21c
spl set id: aa918b1f-8e7f-10d3-e053-2995a90a8e77

Reported adverse events (FAERS/openFDA)#

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