FDA.reportPublic FDA data

MOISTURIZER HAND SANITIZER

Manufacturer
Rinati Skin, LLC
Effective date
2022-10-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:12

Label at a glance#

ProductMOISTURIZER HAND SANITIZER
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

SHAKE WELL BEFORE USE. SPRAY A SMALL AMOUNT OF PRODUCT INTO PALM OF HAND. RUB THOROUGHLY OVER ALL SURFACES OF BOTH HANDS. RUB HANDS TOGETHER BRISKLY UNTIL DRY.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

OTC - PURPOSE SECTION

ANTIMICROBIAL

USE

INDICATIONS & USAGE SECTION

FOR HAND SANITIZING TO DECREASE BACTERIA ON THE SKIN.

RECOMMENDED FOR REPEATED USE.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

IN CASE OF EYE CONTACT, FLUSH EYES WITH WATER. STOP USE AND ASK A DOCTOR IF IRRITATION, OR REDNESS DEVELOPS OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

SHAKE WELL BEFORE USE.

SPRAY A SMALL AMOUNT OF PRODUCT INTO PALM OF HAND.

RUB THOROUGHLY OVER ALL SURFACES OF BOTH HANDS.

RUB HANDS TOGETHER BRISKLY UNTIL DRY.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, PROPYLENE GLYCOL, LINUM USITATISSIMUM (FLAX) SEED EXTRACT, OCIMUM TENUIFLORUM LEAF EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, GLUCONOLACTONE, CITRIC ACID, SODIUM BENZOATE, EUCALYPTUS GLOBULUS OIL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Rinati_Moisturizing Hand Sanitizer 2oz01b LBL_Rinati_Moisturizing Hand Sanitizer 2oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN3
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD3
1049254benzalkonium chloride 0.13 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76849-101-112023-07-28C16284748780-10191ceaa-6735-198a-e063-dbdaa90aec3eRINATI - MOISTURIZING HAND SANITIZER (76849-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76849-101-11MOISTURIZER HAND SANITIZER59 mL in 1 BOTTLESOLUTION593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76849-101MOISTURIZER HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [RINATI SKIN, LLC]3Legacy NDC, 1 package rows20221029_1ea5e840-87b7-4d70-a6f8-502586e4a18e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76849-10176849-101-11

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
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FLAX SEED4110YT348CIACT
OCIMUM TENUIFLORUM TOP34T63W8ULSIACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
GLUCONOLACTONEWQ29KQ9POTIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BENZOATEOJ245FE5EUIACT
EUCALYPTUS OIL2R04ONI662IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
ec20cbf3-a0b4-2173-e053-2995a90a3ddd1ea5e840-87b7-4d70-a6f8-502586e4a18e2022-10-28WarningsExact identifier
spl id: ec20cbf3-a0b4-2173-e053-2995a90a3ddd
spl set id: 1ea5e840-87b7-4d70-a6f8-502586e4a18e

Reported adverse events (FAERS/openFDA)#

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