FDA.reportPublic FDA data

Miracle Origin Hand Sanitizer Gel

Manufacturer
Korea Miracle People Corporation Co.,Ltd
Effective date
2020-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:50

Label at a glance#

ProductMiracle Origin Hand Sanitizer Gel
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

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60ml NDC: 77524-0030-160ml NDC: 77524-0030-1100ml NDC: 77524-0030-2100ml NDC: 77524-0030-2300ml NDC: 77524-0030-3300ml NDC: 77524-0030-3500ml NDC: 77524-0030-4500ml NDC: 77524-0030-4700ml NDC: 77524-0030-5700ml NDC: 77524-0030-51000ml NDC: 77524-0030-61000ml NDC: 77524-0030-63780ml NDC: 77524-0030-73780ml NDC: 77524-0030-760mL NDC: 77524-0030-1

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
77524-0030-12023-01-30C16284748780-1f386c64a-2b76-0266-e053-dadaa90a7c1aa71d8573-c3aa-2b93-e053-2995a90aeeca
77524-0030-22023-01-30C16284748780-1f386c64a-2b76-0266-e053-dadaa90a7c1aa71d8573-c3aa-2b93-e053-2995a90aeeca
77524-0030-32023-01-30C16284748780-1f386c64a-2b76-0266-e053-dadaa90a7c1aa71d8573-c3aa-2b93-e053-2995a90aeeca
77524-0030-42023-01-30C16284748780-1f386c64a-2b76-0266-e053-dadaa90a7c1aa71d8573-c3aa-2b93-e053-2995a90aeeca
77524-0030-52023-01-30C16284748780-1f386c64a-2b76-0266-e053-dadaa90a7c1aa71d8573-c3aa-2b93-e053-2995a90aeeca
77524-0030-62023-01-30C16284748780-1f386c64a-2b76-0266-e053-dadaa90a7c1aa71d8573-c3aa-2b93-e053-2995a90aeeca
77524-0030-72023-01-30C16284748780-1f386c64a-2b76-0266-e053-dadaa90a7c1aa71d8573-c3aa-2b93-e053-2995a90aeeca

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77524-0030-1Miracle Origin Hand Sanitizer Gel60 mL in 1 BOTTLE, PLASTICGEL601
77524-0030-2Miracle Origin Hand Sanitizer Gel100 mL in 1 BOTTLE, PLASTICGEL1001
77524-0030-3Miracle Origin Hand Sanitizer Gel300 mL in 1 BOTTLE, PUMPGEL3001
77524-0030-4Miracle Origin Hand Sanitizer Gel500 mL in 1 BOTTLE, PUMPGEL5001
77524-0030-5Miracle Origin Hand Sanitizer Gel700 mL in 1 BOTTLE, PUMPGEL7001
77524-0030-6Miracle Origin Hand Sanitizer Gel1000 mL in 1 BOTTLE, PUMPGEL10001
77524-0030-7Miracle Origin Hand Sanitizer Gel3780 mL in 1 BOTTLE, PUMPGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77524-0030MIRACLE ORIGIN HAND SANITIZER GEL (ALCOHOL) GEL [KOREA MIRACLE PEOPLE CORPORATION CO.,LTD]1Legacy NDC, 7 package rows20200603_a71d8573-c3aa-2b93-e053-2995a90aeeca.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
77524-003077524-0030-1, 77524-0030-2, 77524-0030-3, 77524-0030-4, 77524-0030-5, 77524-0030-6, 77524-0030-7

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
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9404Q93RCW27EIACT

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
a71d8525-3cd3-aeb5-e053-2995a90aaf10a71d8573-c3aa-2b93-e053-2995a90aeeca2020-06-02WarningsExact identifier
spl id: a71d8525-3cd3-aeb5-e053-2995a90aaf10
spl set id: a71d8573-c3aa-2b93-e053-2995a90aeeca

Reported adverse events (FAERS/openFDA)#

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