MEDICALLY MINDED

Manufacturer
SBL LLC
Effective date
2020-07-14
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:21:19

Label at a glance#

ProductMEDICALLY MINDED
Active ingredientALCOHOL
Label structure14 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

HAND SANITIZER

ANTIMICROBIAL FORMULA

8.5 FL OZ (250 ML)

FRONTFRONT

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

activeactiveAlcohol 70% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Hand Sanitizer Antimicrobial

PurposePurpose

Use

INDICATIONS & USAGE SECTION

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

usageusage

Warnings

WARNINGS SECTION

Warnings: Flammable. Keep away from fire or flame. For external use only. When using this product do not use in or near the eyes. In case of contact, flush thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

warningwarning

Do not use

OTC - DO NOT USE SECTION

  • dont usedont usein 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.

whenwhen

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

stopstop

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.

keep outkeep out

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.
  • dosegedosege

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua), Glycerin, Carbomer, Triethanolamine

inacinac

RECENT MAJOR CHANGES SECTION

mainmain

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER

ANTIMICROBIAL FORMULA

8.5 FL OZ (250 ML)

FRONT2FRONT2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN8
581662ethanol 0.7 ML/ML Topical GelSCD8
581662ethanol 70 % Topical GelSY8
581662ethyl alcohol 70 % Topical GelSY8

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76619-110-01MEDICALLY MINDED250 mL in 1 BOTTLE, PLASTICGEL2508
76619-110-05MEDICALLY MINDED59 mL in 1 BOTTLE, PLASTICGEL598
76619-110-06MEDICALLY MINDED118 mL in 1 BOTTLE, PLASTICGEL1188
76619-110-07MEDICALLY MINDED236 mL in 1 BOTTLE, PLASTICGEL2368
76619-110-08MEDICALLY MINDED500 mL in 1 BOTTLE, PLASTICGEL5008
76619-110-09MEDICALLY MINDED473 mL in 1 BOTTLE, PLASTICGEL4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76619-110MEDICALLY MINDED (ALCOHOL) GEL [SBL LLC]8Legacy NDC, 6 package rows20200715_a40314a7-7b33-a2a5-e053-2a95a90aa514.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76619-11076619-110-01, 76619-110-05, 76619-110-06, 76619-110-07, 76619-110-08, 76619-110-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
aa6ce0c1-a67e-3f73-e053-2995a90a729ea40314a7-7b33-a2a5-e053-2a95a90aa5142020-07-14WarningsExact identifier
spl id: aa6ce0c1-a67e-3f73-e053-2995a90a729e
spl set id: a40314a7-7b33-a2a5-e053-2a95a90aa514

Reported adverse events (FAERS/openFDA)#

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