Premium Hand Sanitizer Gel

Manufacturer: Renowned Chemical Solutions Llc
Effective date: 2020-06-10
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:17:16

Label at a glance#

ProductPremium Hand Sanitizer Gel PSG

Active ingredientALCOHOL

Label structure9 sections

Dosage and administration

• Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

• Store between 15-30°C (59-86°F) • Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

• Store between 15-30°C (59-86°F)

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients glycerin, hydrogen peroxide, purified water, triethanolamine, carbomer, propylene glycol

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 70%

Topical Solution

Hand Sanitizer

Non-sterile Solution

Renowned Trading, LLC 18465 FM 362 RD, Waller, TX 77484

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581662	ethanol 70 % Topical Gel	PSN	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	1
581662	ethanol 70 % Topical Gel	SY	1
581662	ethyl alcohol 70 % Topical Gel	SY	1

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
74837-002-06	2022-01-28	C162847	48780-1	d6a99b39-8f17-a426-e053-dadaa90af4c2	RENOWNED Premium Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
74837-002-06	Premium Hand Sanitizer GelPSG	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
74837-002	PREMIUM HAND SANITIZER GEL PSG (ALCOHOL) GEL [RENOWNED CHEMICAL SOLUTIONS LLC]	1	Legacy NDC, 1 package rows	20200612_24a925b8-92d8-4401-bfc5-d3e476451bac.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Premium Hand Sanitizer Gel PSG
Alcohol
GLYCERIN
HYDROGEN PEROXIDE
WATER
TROLAMINE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
PROPYLENE GLYCOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
74837-002	74837-002-06

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
ALCOHOL	3K9958V90M	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
WATER	059QF0KO0R	IACT
TROLAMINE	9O3K93S3TK	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
PROPYLENE GLYCOL	6DC9Q167V3	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
34f16f21-47bc-4b28-8af3-d4eecf925f13			24a925b8-92d8-4401-bfc5-d3e476451bac	2020-06-10	Warnings	Exact identifier spl id: 34f16f21-47bc-4b28-8af3-d4eecf925f13 spl set id: 24a925b8-92d8-4401-bfc5-d3e476451bac

Reported adverse events (FAERS/openFDA)#

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