Hand sanitizer

Manufacturer: PurCel Labs LLC | Jiangsu Intco Medical Products Co., Ltd
Effective date: 2023-07-24
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:55:43

Label at a glance#

ProductHand sanitizer

Active ingredientALCOHOL

Label structure12 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

• Put enough product in your palm to cover hands and rub hands together briskly until dry. • Children under 6 years of age should be supervised when using products.

Storage and handling

• Store below 110°F (43°C). • Avoid freezing and excessive heat above 104°F (40°C). • May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Wamings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

• On children less than 2 months of age. • On open skin wounds.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. 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

• Put enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using products.

Other information

STORAGE AND HANDLING SECTION

• Store below 110°F (43°C).

• Avoid freezing and excessive heat above 104°F (40°C).

• May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Carbomer Interpolymer (type B)，Lemon oil， Glycerin, Triethanolamine, Water (Aqua).

Package label.principal display panel

16oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581662	ethanol 70 % Topical Gel	PSN	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	2
581662	ethanol 70 % Topical Gel	SY	2
581662	ethyl alcohol 70 % Topical Gel	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
83584-016-01	2025-01-30	C162847	48780-1	2cef2736-8e98-d83d-e063-dadaa90ab31f	00e15fc7-133e-beb2-e063-6294a90a1698

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83584-016-01	Hand sanitizer	473 mL in 1 BOTTLE, PUMP	GEL	473		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83584-016	HAND SANITIZER (ALCOHOL GEL) GEL [PURCEL LABS LLC]	2	1 package rows	20230725_00e15fc7-133e-beb2-e063-6294a90a1698.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Hand sanitizer
Alcohol gel
GLYCERIN
ALOE VERA LEAF
TRIETHANOLAMINE DODECYLBENZENESULFONATE
ALCOHOL
WATER
LEMON OIL
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83584-016	83584-016-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
TRIETHANOLAMINE DODECYLBENZENESULFONATE	8HM7ZD48HN	IACT
ALCOHOL	3K9958V90M	ACTIB
WATER	059QF0KO0R	IACT
LEMON OIL	I9GRO824LL	IACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	132584PQMO	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
013d22cd-1088-8cf9-e063-6294a90ab860			00e15fc7-133e-beb2-e063-6294a90a1698	2023-07-24	Warnings	Exact identifier spl id: 013d22cd-1088-8cf9-e063-6294a90ab860 spl set id: 00e15fc7-133e-beb2-e063-6294a90a1698

Reported adverse events (FAERS/openFDA)#

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