FDA.reportPublic FDA data

FormoClean Gel Hand Sanitizer

Manufacturer
Applichem, Inc
Effective date
2020-11-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:33:36

Label at a glance#

ProductFormoClean Gel Hand Sanitizer
Active ingredientALCOHOL
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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

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

Medicinal ingredient: Ethyl 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. 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

OTC - DO NOT USE SECTION

  • in 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 (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.8 L NDC: 74751-003-01

1 Gallon Sleeve1 Gallon Sleeve1 Gal Front1 Gal Front

1 Gal Black1 Gal Black

19 L NDC: 74751-003-05

5 Gallon5 Gallon

189 L NDC: 74751-003-50

50 Gallon50 Gallon

250 mL NDC: 74751-003-08

8 oz8 oz500 mL NDC: 74751-003-16

16 oz16 oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74751-004-012022-07-29C16284748780-1e4f33bdf-b2ec-d8a0-e053-dadaa90a6e4ea821f803-7163-252c-e053-2a95a90a1068
74751-004-052022-07-29C16284748780-1e4f33bdf-b2ec-d8a0-e053-dadaa90a6e4ea821f803-7163-252c-e053-2a95a90a1068
74751-004-082022-07-29C16284748780-1e4f33bdf-b2ec-d8a0-e053-dadaa90a6e4ea821f803-7163-252c-e053-2a95a90a1068
74751-004-162022-07-29C16284748780-1e4f33bdf-b2ec-d8a0-e053-dadaa90a6e4ea821f803-7163-252c-e053-2a95a90a1068
74751-004-502022-07-29C16284748780-1e4f33bdf-b2ec-d8a0-e053-dadaa90a6e4ea821f803-7163-252c-e053-2a95a90a1068

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74751-004-01FormoClean Gel Hand Sanitizer3800 mL in 1 BOTTLE, PLASTICGEL38004
74751-004-05FormoClean Gel Hand Sanitizer19000 mL in 1 PAILGEL190004
74751-004-08FormoClean Gel Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2504
74751-004-16FormoClean Gel Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5004
74751-004-50FormoClean Gel Hand Sanitizer190000 mL in 1 DRUMGEL1900004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74751-004FORMOCLEAN GEL HAND SANITIZER (ALCOHOL) GEL [APPLICHEM, INC]4Legacy NDC, 5 package rows20201114_a821f803-7163-252c-e053-2a95a90a1068.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
74751-00474751-004-01, 74751-004-05, 74751-004-50, 74751-004-08, 74751-004-16

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
MYRISTYL LACTATE1D822OC34XIACT
ALOE VERA LEAFZY81Z83H0XIACT
WEST INDIAN LEMONGRASS OIL5BIA40E9EDIACT

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
b4037a81-6036-ae11-e053-2a95a90a959ca821f803-7163-252c-e053-2a95a90a10682020-11-13WarningsExact identifier
spl id: b4037a81-6036-ae11-e053-2a95a90a959c
spl set id: a821f803-7163-252c-e053-2a95a90a1068

Reported adverse events (FAERS/openFDA)#

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