Premium Nature Instant hand sanitizer

Manufacturer: Premium Assure Inc
Effective date: 2021-02-05
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:37:49

Label at a glance#

ProductPremium Nature Instant hand sanitizer

Active ingredientALCOHOL

Label structure10 sections

Indications and uses

For hand sanitizing to decrease bacteria on skin Recommended for repeated use

Dosage and administration

Squeeze appropriate amount of sanitizer on to hands and rub together until dry. Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

PURPOSE

OTC - PURPOSE SECTION

Antiseptic hand sanitizer

USES

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on skin

Recommended for repeated use

WARNINGS

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame.

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.

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

Squeeze appropriate amount of sanitizer on to hands and rub together until dry.

Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF EXTRACT, WATER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,TETRAHYDROXYPROPYL ETHYLENEDIAMINE

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118mL NDC: 75821-001-01

118ml label236mL NDC: 75821-001-02

236ml label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
902574	ethanol 65 % Topical Gel	PSN	4
902574	ethanol 0.65 ML/ML Topical Gel	SCD	4
902574	ethyl alcohol 65 % Topical Gel	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75821-001-01	2022-07-29	C162847	48780-1	e4f33bdf-a1c9-d8a0-e053-dadaa90a6e4e	a3f42a32-aed8-44f1-e053-2a95a90a5a0c
75821-001-02	2022-07-29	C162847	48780-1	e4f33bdf-a1c9-d8a0-e053-dadaa90a6e4e	a3f42a32-aed8-44f1-e053-2a95a90a5a0c
75821-001-03	2022-07-29	C162847	48780-1	e4f33bdf-a1c9-d8a0-e053-dadaa90a6e4e	a3f42a32-aed8-44f1-e053-2a95a90a5a0c
75821-001-04	2022-07-29	C162847	48780-1	e4f33bdf-a1c9-d8a0-e053-dadaa90a6e4e	a3f42a32-aed8-44f1-e053-2a95a90a5a0c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75821-001-01	Premium Nature Instant hand sanitizer	118 mL in 1 BOTTLE, PLASTIC	GEL	118	4
75821-001-02	Premium Nature Instant hand sanitizer	236 mL in 1 BOTTLE, PLASTIC	GEL	236	4
75821-001-03	Premium Nature Instant hand sanitizer	473 mL in 1 BOTTLE, PLASTIC	GEL	473	4
75821-001-04	Premium Nature Instant hand sanitizer	3785.41 mL in 1 BOTTLE	GEL	3785.41	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75821-001	PREMIUM NATURE INSTANT HAND SANITIZER (ALCOHOL) GEL [PREMIUM ASSURE INC]	4	Legacy NDC, 4 package rows	20210206_a3f42a32-aed8-44f1-e053-2a95a90a5a0c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Premium Nature Instant hand sanitizer
ALCOHOL
EDETOL
ALOE VERA LEAF
WATER
CARBOMER INTERPOLYMER TYPE A (55000 CPS)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
75821-001	75821-001-01, 75821-001-02, 75821-001-03, 75821-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
EDETOL	Q4R969U9FR	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
WATER	059QF0KO0R	IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)	59TL3WG5CO	IACT
ALCOHOL	3K9958V90M	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ba9ad215-bd67-bf0d-e053-2a95a90abe79			a3f42a32-aed8-44f1-e053-2a95a90a5a0c	2021-02-05	Warnings	Exact identifier spl id: ba9ad215-bd67-bf0d-e053-2a95a90abe79 spl set id: a3f42a32-aed8-44f1-e053-2a95a90a5a0c

Reported adverse events (FAERS/openFDA)#

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