FDA.reportPublic FDA data

MEDICALLY MINDED

Manufacturer
SBL LLC
Effective date
2020-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:13

Label at a glance#

ProductMEDICALLY MINDED
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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

ACTIVEACTIVEAlcohol 70% v/v. Purpose: ANTIMICROBIAL

Purpose

OTC - PURPOSE SECTION

AntIMICROBIAL PURPUSEPURPUSE, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

USAGEUSAGEHand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

USINGUSINGWhen 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

STOPSTOPStop 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

KEEPKEEPKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • DOSAGEDOSAGEPlace 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

  • STORAGESTORAGEStore between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

INACTIVEINACTIVEWATER, TRIETHANOLAMINE, CARBOMER

RECENT MAJOR CHANGES SECTION

MAJORMAJOR

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRONTFRONTHAND SANITIZER GEL

6.5 FL OZ (194 ML)

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130676753003645GTIN-13: 0676753003645
EAN-13: 0676753003645
GTIN-12: 676753003645
UPC-A: 676753003645
GTIN storage (14 digits): 00676753003645		MM 195ML BACK.jpg
QR code linkQR Codegstqualityassurance.com/SDS/MedicallyMinded/SDS-MM-676753364.pdfMM 195ML BACK.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76619-110-042022-01-28C16284748780-1d6a99b39-7081-a426-e053-dadaa90af4c2a49486ac-a82e-55c3-e053-2a95a90a0021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76619-110-04MEDICALLY MINDED194 mL in 1 BOTTLE, PLASTICGEL1941

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76619-110MEDICALLY MINDED (ALCOHOL) GEL [SBL LLC]1Legacy NDC, 1 package rows20200501_a49486ac-a82e-55c3-e053-2a95a90a0021.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76619-11076619-110-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
CARBOMER 934Z135WT9208IACT
WATER059QF0KO0RIACT
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
a493eadb-3e3b-2476-e053-2995a90ac70da49486ac-a82e-55c3-e053-2a95a90a00212020-05-01WarningsExact identifier
spl id: a493eadb-3e3b-2476-e053-2995a90ac70d
spl set id: a49486ac-a82e-55c3-e053-2a95a90a0021

Reported adverse events (FAERS/openFDA)#

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