FDA.reportPublic FDA data

AGACHY FAST CLEAN HAND SANITIZER

Manufacturer
ICOMAX Co., Ltd.
Effective date
2020-05-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:15:08

Label at a glance#

ProductAGACHY FAST CLEAN HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on your palm to cover all surfaces and rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surface

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

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product do not use in or near the eye. In case of contact with eyes, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

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 your palm to cover all surfaces and 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

  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surface

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 77201-002-50 500 mL NDC: 77201-002-50500 mL NDC: 77201-002-50

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77201-002-502022-01-28C16284748780-1d6a99b39-f392-a426-e053-dadaa90af4c2a5a7d5d4-d740-119f-e053-2a95a90ad516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77201-002-50AGACHY FAST CLEAN HAND SANITIZER500 mL in 1 BOTTLE, PUMPGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77201-002AGACHY FAST CLEAN HAND SANITIZER (HAND SANITIZER) GEL [ICOMAX CO., LTD.]3Legacy NDC, 1 package rows20200529_a5a7d5d4-d740-119f-e053-2a95a90ad516.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77201-00277201-002-50

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
HYALURONATE SODIUMYSE9PPT4THIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
WATER059QF0KO0RIACT
LEVOMENTHOLBZ1R15MTK7IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB

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
a6b194ef-820d-5190-e053-2a95a90acf58a5a7d5d4-d740-119f-e053-2a95a90ad5162020-05-28WarningsExact identifier
spl id: a6b194ef-820d-5190-e053-2a95a90acf58
spl set id: a5a7d5d4-d740-119f-e053-2a95a90ad516

Reported adverse events (FAERS/openFDA)#

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