FDA.reportPublic FDA data

NDC-63148-516

Manufacturer
Apollo Health and Beauty Care
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:56:23

Label at a glance#

ProductNatural Concepts Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Dosage and administration

Adults only For occasional and personal use Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol (65%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

  • Flammable
  • Keep away from source of heat or fire.

Do not use

OTC - DO NOT USE SECTION

  • On infants less than 2 months of age
  • On open skin wounds.
  • On broken or damaged skin.

When using this Product

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or redness develops and lasts.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults only
  • For occasional and personal use
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice,,AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Fragrance (Parfum), Glycerin, Isopropyl Alcohol, Isopropyl Myristate, PEG-6, Tocopheryl Acetate, Water.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-695-3030

Principal Display Panel (8 oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

Principal Display Panel (32 oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN5
902574ethanol 0.65 ML/ML Topical GelSCD5
902574ethyl alcohol 65 % Topical GelSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130670456000536GTIN-13: 0670456000536
EAN-13: 0670456000536
GTIN-12: 670456000536
UPC-A: 670456000536
GTIN storage (14 digits): 00670456000536		PDP-1 (8 FL oz).jpg
BarcodeEAN-130670456000543GTIN-13: 0670456000543
EAN-13: 0670456000543
GTIN-12: 670456000543
UPC-A: 670456000543
GTIN storage (14 digits): 00670456000543		PDP-2 (32 FL oz).jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-516-032025-02-01C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-032025-02-01C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-092025-02-01C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-092025-02-01C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-332025-02-01C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-332025-02-01C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-032025-01-30C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-032025-01-30C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-092025-01-30C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-092025-01-30C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-332025-01-30C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516
63148-516-332025-01-30C16284748780-12cef2736-751e-d83d-e063-dadaa90ab31fNDC-63148-516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-516-03Natural Concepts Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL595
63148-516-09Natural Concepts Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2365
63148-516-33Natural Concepts Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9465

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
63148-51663148-516-03, 63148-516-09, 63148-516-33

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
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)2N8MDB79NAIACT
WATER059QF0KO0RIACT
PEG-65655G9Y8AQIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-11-17monthly-update2026-06-03 17:40:14

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
Natural Concepts Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Careb25bbf28-f08d-4de2-9be7-bfb6b134b49a2026-05-07WarningsExact identifier
ndc (package): 63148-516-03
ndc (package): 63148-516-09
ndc (package): 63148-516-33
ndc (product): 63148-516
ndc11 (package): 63148051633
ndc11 (package): 63148051609
ndc11 (package): 63148051603
spl id: 513b7d15-7d64-3775-e063-6394a90adf9c
spl set id: b25bbf28-f08d-4de2-9be7-bfb6b134b49a

Reported adverse events (FAERS/openFDA)#

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