Premium hand sanitrizer

Manufacturer: PORT ROYAL SALES, LTD.
Effective date: 2020-06-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:19:38

Label at a glance#

ProductPremium hand sanitrizer

Active ingredientALCOHOL

Label structure11 sections

Indications and uses

• Hand sanitizer to help decrease bacteria on the skin when soap and towel are not available. • Recommended for repeated use

Dosage and administration

Place enough product into your palms and thoroughly spread on both hands. • Rub into skin until dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• Hand sanitizer to help decrease bacteria on the skin when soap and towel are not available. • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame • Do not apply around eyes • Do not use in ears or mouth

When using this product

OTC - WHEN USING SECTION

avoid contact eith eyes. In case of eye contact flush eyes with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children must be supervised in use of this product.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product into your palms and thoroughly spread on both hands. • Rub into skin until dry.

Other information

SPL UNCLASSIFIED SECTION

Store below 110ºF (43ºC). May discolor certain surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, triethanolamine, glycerine, water.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1305100	ethanol 75 % Topical Gel	PSN	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	1
1305100	ethanol 75 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78620-001-16	2022-01-28	C162847	48780-1	d6a99b39-8f32-a426-e053-dadaa90af4c2	Premium Port Royal Hand Sanitizer75

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78620-001-16	Premium hand sanitrizer	500 mL in 1 BOTTLE, PLASTIC	GEL	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78620-001	PREMIUM HAND SANITRIZER (ALCOHOL) GEL [PORT ROYAL SALES, LTD.]	1	Legacy NDC, 1 package rows	20200701_a8b2e9f7-73f8-7d63-e053-2995a90a8e1a.zip

Products#

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

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

Premium hand sanitrizer
Alcohol
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
WATER
TROLAMINE
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
78620-001	78620-001-16

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB
TROLAMINE	9O3K93S3TK	IACT
GLYCERIN	PDC6A3C0OX	IACT

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
a8b2e9f7-73f9-7d63-e053-2995a90a8e1a			a8b2e9f7-73f8-7d63-e053-2995a90a8e1a	2020-06-22	Warnings	Exact identifier spl id: a8b2e9f7-73f9-7d63-e053-2995a90a8e1a spl set id: a8b2e9f7-73f8-7d63-e053-2995a90a8e1a

Reported adverse events (FAERS/openFDA)#

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