FDA.reportPublic FDA data

Miracle Health Gel Hand Sanitizer

Manufacturer
CORONET CERAMICS, INC.
Effective date
2020-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:59

Label at a glance#

ProductMiracle Health Gel Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Dosage and administration

Place enough product in your palm to cover hands. Rub hands togethe until dry.  Children under 6 years of age should be supervised when using this product. Other Information Do not store above 110 F (43 C). May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70%  v/v.

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • Helps reduce bacteria and viruses on the skin that could cause disease.
  • Recommended for repeated use.
  • Do not ingest, for topical use only.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

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 in your palm to cover hands. Rub hands togethe until dry. 
  • Children under 6 years of age should be supervised when using this product.

Other Information

  • Do not store above 110 F (43 C).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Acrylates/C10 Alkyl Arcylate, Aloe Barlladensis Leaf Juice. Glycerin, Tocopherol Acetate, Fragrance, Triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN1
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD1
581698isopropyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90090-001-012022-01-28C16284748780-1d6a99b39-7813-a426-e053-dadaa90af4c287336e31-4282-4b96-bf80-ccb6f11a2b0d
90090-001-022022-01-28C16284748780-1d6a99b39-7813-a426-e053-dadaa90af4c287336e31-4282-4b96-bf80-ccb6f11a2b0d
90090-001-032022-01-28C16284748780-1d6a99b39-7813-a426-e053-dadaa90af4c287336e31-4282-4b96-bf80-ccb6f11a2b0d
90090-001-042022-01-28C16284748780-1d6a99b39-7813-a426-e053-dadaa90af4c287336e31-4282-4b96-bf80-ccb6f11a2b0d
90090-001-052022-01-28C16284748780-1d6a99b39-7813-a426-e053-dadaa90af4c287336e31-4282-4b96-bf80-ccb6f11a2b0d
90090-001-062022-01-28C16284748780-1d6a99b39-7813-a426-e053-dadaa90af4c287336e31-4282-4b96-bf80-ccb6f11a2b0d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90090-001-01Miracle Health Gel Hand Sanitizer59 mL in 1 BOTTLE, PUMPGEL591
90090-001-02Miracle Health Gel Hand Sanitizer118 mL in 1 BOTTLE, PUMPGEL1181
90090-001-03Miracle Health Gel Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL2361
90090-001-04Miracle Health Gel Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4731
90090-001-05Miracle Health Gel Hand Sanitizer946 mL in 1 BOTTLE, PUMPGEL9461
90090-001-06Miracle Health Gel Hand Sanitizer3785 mL in 1 BOTTLE, PUMPGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90090-001MIRACLE HEALTH GEL HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [CORONET CERAMICS, INC.]1Legacy NDC, 6 package rows20200807_87336e31-4282-4b96-bf80-ccb6f11a2b0d.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90090-00190090-001-01, 90090-001-02, 90090-001-03, 90090-001-04, 90090-001-05, 90090-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
TROLAMINE9O3K93S3TKIACT

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
a99b49bb-3a46-4438-9b4c-bb9dc83f1dce87336e31-4282-4b96-bf80-ccb6f11a2b0d2020-08-04WarningsExact identifier
spl id: a99b49bb-3a46-4438-9b4c-bb9dc83f1dce
spl set id: 87336e31-4282-4b96-bf80-ccb6f11a2b0d

Reported adverse events (FAERS/openFDA)#

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