Label at a glance#

ProductHand Sanitizer Gel

Active ingredientALCOHOL

Label structure10 sections

Indications and uses

• hand sanitizer to help reduce bacteria on the skin that potentially can cause disease • recommend for repeated use

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Children under 6 years of age should be supervised when using this product

Storage and handling

• Store between 15°-30°C (59°86°F) • Avoid freezing and excessive heat above 40°C (104°F) • may discolor certain fabrics or surfaces

Contacts and useful links#

PhoneLabel contact1-888-333-9792

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• hand sanitizer to help reduce bacteria on the skin that potentially can cause disease
• recommend for repeated use

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat and flame.
Do not use • in children less than 2 months of age
• on open skin wounds
___________________________________________________________________________
When using this product
• keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
___________________________________________________________________________
Stop use and ask a doctor if irritation or rash appears and lasts. These may be signs of a serious condition.

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

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Children under 6 years of age should be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

• Store between 15°-30°C (59°86°F)
• Avoid freezing and excessive heat above 40°C (104°F)
• may discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkinium chloride, fragrance, glycerin, hydrogen peroxide, isopropyl myristate, propylene glycol, tocopheryl acetate, water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

Manufactured by: APL

P.O. Box 7771, Ajman, UAE

Under License From

MODD PERFUMES & COSMETICS

10 Cameron Road, Seven Kings

London, IG3 8LA

United Kingdom

For external use only

Made in U.A.E.

Distributed By:

Spirit Pharamceuticals LLC

Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HANDY

HAND-SANITIZER SOLUTION

EFFECTIVELY KILLS 99.9% OF THE

MOST COMMON GERMS/ BACTERIA

70%

ALCOHOL CONTENT

WITH

VITAMIN E & MOISTURIZERS

PLEASANT FRAGRANCE

STAY PROTECTED

16.9 FL. OZ. (500 ml)

MODD

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
582753	ethanol 70 % Topical Solution	PSN	4
582753	ethanol 0.7 ML/ML Topical Solution	SCD	4
582753	ethanol 70 % Topical Solution	SY	4
582753	ethyl alcohol 70 % Topical Solution	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68210-4082-5	2024-01-30	C162847	48780-1	1030e365-0fd1-111a-e063-dadaa90a10e2	HAND SANITIZER SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4082-5	Hand Sanitizer Gel	500 mL in 1 BOTTLE	SOLUTION	500		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4082	HAND SANITIZER GEL (ETHYL ALCOHOL) SOLUTION [SPIRIT PHARMACEUTICALS LLC]	4	Legacy NDC, 1 package rows	20221206_419bfa23-6958-440c-88fc-5da9c94cd6f1.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Hand Sanitizer Gel
Ethyl Alcohol
BENZALKONIUM CHLORIDE
GLYCERIN
HYDROGEN PEROXIDE
ISOPROPYL MYRISTATE
PROPYLENE GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68210-4082	68210-4082-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
WATER	059QF0KO0R	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
ef1ad8bb-319a-14bc-e053-2995a90ab192			419bfa23-6958-440c-88fc-5da9c94cd6f1	2022-12-05	Warnings	Exact identifier spl id: ef1ad8bb-319a-14bc-e053-2995a90ab192 spl set id: 419bfa23-6958-440c-88fc-5da9c94cd6f1

Reported adverse events (FAERS/openFDA)#

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