FDA.reportPublic FDA data

ALLOUT NANO

Manufacturer
SERENITY TECHNOLOGIES INC.
Effective date
2020-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:24

Label at a glance#

ProductALLOUT NANO
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Indications and uses

HAND SANITIZER TO HELP REDUCE GERMS ON THE SKIN WHEN SOAP AND WATER ARE NOT AVAILABLE.

Dosage and administration

APPLY PRODUCT TO HANDS THOROUGHLY, RUB HANDS TOGETHER UNTIL DRY.

Storage and handling

CONTAINS PPM LEVELS OF SUB-MICRON AND NANO PARTICLES OF COPPER, ZINC AND SILVER STORE BETWEEN 15-30C (59-86F) AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ISOPROPYL ALCOHOL 75% v/v.

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

HAND SANITIZER TO HELP REDUCE GERMS ON THE SKIN WHEN SOAP AND WATER ARE NOT AVAILABLE.

WARNINGS

WARNINGS SECTION

FLAMMABLE, KEEP AWAY FROM FIRE AND FLAMES. FOR EXTERNAL USE ONLY.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT KEEP OUT OF EYES. IN CASE OF CONTACT WITH EYES RINSE EYES THOROUGHLY WITH WATER.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF IRRITATION AND REDNESS DEVELOP AND 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 OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY PRODUCT TO HANDS THOROUGHLY, RUB HANDS TOGETHER UNTIL DRY.

OTHER INFO

STORAGE AND HANDLING SECTION

  • CONTAINS PPM LEVELS OF SUB-MICRON AND NANO PARTICLES OF COPPER, ZINC AND SILVER
  • STORE BETWEEN 15-30C (59-86F)
  • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF EXTRACT, ALUM, COPPER, ESTER, GLYCERINE, HYALURONIC ACID, HYDROXYPROPYL CELLULOSE, SILVER, WATER, WHITE CAMPHOR OIL, ZINC.

SPL UNCLASSIFIED SECTION

Manufactured By:
Serenity Technologies Inc.
43320 Business Park Dr., B105
Temecula, CA 92590

PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NANOTECHNOLOGY

ALLOUT™
NANO

ADVANCED
HAND SANITIZER

LONG LASTING
ANTIMICROBIAL PROTECTION
FORMULATED WITH
COPPER, SILVER AND ZINC

GEL

SKIN NOURISHING
WITH HYALURONIC ACID

CLEAN HANDS
COUNT

2 fl oz (59.1 ml)

PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN1
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD1
2285607isopropyl alcohol 75 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75814-104-012022-01-28C16284748780-1d6a99b39-9397-a426-e053-dadaa90af4c2ALLOUT™ NANO
75814-104-022022-01-28C16284748780-1d6a99b39-9397-a426-e053-dadaa90af4c2ALLOUT™ NANO
75814-104-062022-01-28C16284748780-1d6a99b39-9397-a426-e053-dadaa90af4c2ALLOUT™ NANO
75814-104-082022-01-28C16284748780-1d6a99b39-9397-a426-e053-dadaa90af4c2ALLOUT™ NANO
75814-104-342022-01-28C16284748780-1d6a99b39-9397-a426-e053-dadaa90af4c2ALLOUT™ NANO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75814-104-01ALLOUT NANO29.6 mL in 1 BOTTLE, PUMPGEL29.61
75814-104-02ALLOUT NANO59.1 mL in 1 BOTTLE, PUMPGEL59.11
75814-104-06ALLOUT NANO177.4 mL in 1 BOTTLE, PUMPGEL177.41
75814-104-08ALLOUT NANO236.6 mL in 1 BOTTLE, PUMPGEL236.61
75814-104-34ALLOUT NANO1000 mL in 1 BOTTLE, PUMPGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75814-104ALLOUT NANO (ISOPROPYL ALCOHOL) GEL [SERENITY TECHNOLOGIES INC.]1Legacy NDC, 5 package rows20200812_0c75f995-4082-4d73-af2c-ca1522c2c8d9.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
75814-10475814-104-01, 75814-104-02, 75814-104-06, 75814-104-08, 75814-104-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
POTASSIUM ALUM1L24V9R23SIACT
SILVER3M4G523W1GIACT
COPPER789U1901C5IACT
PYRITHIONE ZINCR953O2RHZ5IACT
CAMPHOR OIL, WHITE26P3H26Z9XIACT
HYALURONIC ACIDS270N0TRQYIACT
ALOE VERA LEAFZY81Z83H0XIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
LAURYL LACTATEG5SU0BFK7OIACT
GLYCERINPDC6A3C0OXIACT

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
0d30a5c7-c011-491f-9950-f99d6058a2690c75f995-4082-4d73-af2c-ca1522c2c8d92020-08-10WarningsExact identifier
spl id: 0d30a5c7-c011-491f-9950-f99d6058a269
spl set id: 0c75f995-4082-4d73-af2c-ca1522c2c8d9

Reported adverse events (FAERS/openFDA)#

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