FDA.reportPublic FDA data

Royal Hand Sanitizer

Manufacturer
GPM Investments LLC | Shanghai Kejing Cleaning Products Co., Ltd.
Effective date
2013-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:34:12

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Ethyl Alcohol 62 percent

Purpose

Antimicrobial

Uses

Use

hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

Warnings

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

Stop use and ask a doctor if

irritation and redness develops and persists.

Directions And Dosage

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Label Information

Stop use and ask a doctor if

irritation and redness develops and persists.

Other information

Store under 105 degrees F

Inactive ingredients

Water, PEG12-Dimethicone, Carbomer, Fragrance. Aloe Barbadersis Leaf Juice, Triethanolamine.

Package label

ROYAL ALOE Hand Sanitizer CAUTION:EYE IRRITANT! MAY BE HARMFUL IF SWALLOWED. SEE CAUTION ON BACK PANEL. 2 fl oz 60ml Made in China

Label Images#

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN2
581660ethanol 0.62 ML/ML Topical GelSCD2
581660ethanol 62 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55439-000-602019-11-27C16284748780-19855d018-e699-cd31-e053-dbdaa90ab51aRoyal Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55439-000-60Royal Hand Sanitizer60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55439-000ROYAL HAND SANITIZER (ALCOHOL) GEL [GPM INVESTMENTS LLC]2Legacy NDC, 1 package rows20130110_08edae13-e1f2-4fd2-860f-eace27b4b07b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M2
ALCOHOLACTIVE MOIETY3K9958V90M2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55439-00055439-000-60

Ingredients#

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT

Complete SPL Sections#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62 percent

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

Do not use in eyes. In case of contact with eyes, rinse with water

Stop use and ask a doctor if

STORAGE AND HANDLING SECTION

irritation and redness develops and persists.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help promptly.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

Other information

STORAGE AND HANDLING SECTION

Store under 105 degrees F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, PEG12-Dimethicone, Carbomer, Fragrance. Aloe Barbadersis Leaf Juice, Triethanolamine.

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROYAL ALOE Hand Sanitizer CAUTION:EYE IRRITANT! MAY BE HARMFUL IF SWALLOWED. SEE CAUTION ON BACK PANEL. 2 fl oz 60ml Made in China

Source Document#

Source XML