FDA.reportPublic FDA data

MDR Safe-In-Seconds Hand Sanitizer

Manufacturer
Clientele, Inc.
Effective date
2020-10-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:35

Label at a glance#

ProductMDR Safe-In-Seconds Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Wet hands thoroughly with product. Briskly rub hands together until dry. Supervise children under 6 years in the use of this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from heat or flame.

For external use only

When using this product

OTC - WHEN USING SECTION

do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product. Briskly rub hands together until dry. Supervise children under 6 years in the use of this product.

Other Information

OTHER SAFETY INFORMATION

Store below 110F (43C). May discolor certain fabrics and surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Myristate, Glycerin, Cinnamomum Cassia Bark/Syzgium Aromaticum Bud/Rosmarinus Officianalis (Rosemary) Leaf/Thymus Vulgaris (Thyme) Leaf Oil, Carbomer, Tetrahydroxypropyl Ethylenediamine.

Company Information

SPL UNCLASSIFIED SECTION

MDR.COM

800.637.8227

Distributed by MDR Fitness Corp., Sunrise, Fl 33325

Product Packaging - 236 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MDR

Medical Doctors Research

Safe-In-Seconds

Hand Sanitizer

  • Kills 99.9% of Germs
  • 70% Alcohol
  • With Clove, Thyme, Cinnamon, Rosemary
  • Cruelty-Free

8 Fl Oz (236 mL)

mdrmdr

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
64483-010-012022-01-28C16284748780-1d6a99b39-496b-a426-e053-dadaa90af4c2MDR Safe-In-Seconds Hand Sanitizer
64483-010-022022-01-28C16284748780-1d6a99b39-496b-a426-e053-dadaa90af4c2MDR Safe-In-Seconds Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64483-010-01MDR Safe-In-Seconds Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1181
64483-010-02MDR Safe-In-Seconds Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64483-010MDR SAFE-IN-SECONDS HAND SANITIZER (ALCOHOL) GEL [CLIENTELE, INC.]1Legacy NDC, 2 package rows20201029_b2be143a-c6b4-2b8b-e053-2a95a90ab148.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64483-01064483-010-01, 64483-010-02

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
GLYCERINPDC6A3C0OXIACT
CHINESE CINNAMONWS4CQ062KMIACT
SYZYGIUM AROMATICUM WHOLEEY9MMA0P6YIACT
ROSEMARYIJ67X351P9IACT
ALCOHOL3K9958V90MACTIB
THYME OIL2UK410MY6BIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
EDETOLQ4R969U9FRIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT

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
b2bd8afe-eb13-67ed-e053-2a95a90a81bdb2be143a-c6b4-2b8b-e053-2a95a90ab1482020-10-28WarningsExact identifier
spl id: b2bd8afe-eb13-67ed-e053-2a95a90a81bd
spl set id: b2be143a-c6b4-2b8b-e053-2a95a90ab148

Reported adverse events (FAERS/openFDA)#

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