Antibacterial Hand Sanitizer

Manufacturer: Royal Deluxe Accessories Llc
Effective date: 2020-04-28
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:10:03

Label at a glance#

ProductAntibacterial Hand Sanitizer

Active ingredientALCOHOL

Label structure9 sections

Indications and uses

• To help reduce bacteria on the skin.

Dosage and administration

• put enough product in your palm to cover hands and rub hands together until dry. • for children under 6, use only under adult supervision. • not recommended for infants.

Storage and handling

store at a temperature below 110°F.(43°C). may discolor some fabrics.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• To help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

When using this product • avoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor if skin irritation or redness develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• put enough product in your palm to cover hands and rub hands together until dry. • for children under 6, use only under adult supervision.

• not recommended for infants.

Other information:

STORAGE AND HANDLING SECTION

store at a temperature below 110°F.(43°C).
may discolor some fabrics.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Fragrance, Triethanolamine, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), FD&C Yellow No.5 (Tartrazine), FD&C Blue No.1.

SPL UNCLASSIFIED SECTION

KILLS GERMS WITHOUT WATER

Effective at eliminating over 99.99% of many common harmful germs and bacteria.

Distributed by:Royal Deluxe Accessories,LLC

Made in China / Fabrique'en Chine / Hecho en China

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
247835	ethanol 62 % Topical Solution	PSN	1
247835	ethanol 0.62 ML/ML Topical Solution	SCD	1
247835	ethanol 62 % Topical Solution	SY	1
247835	ethyl alcohol 62 % Topical Solution	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77043-166-01	2022-01-28	C162847	48780-1	d6a99b39-576b-a426-e053-dadaa90af4c2	Antibacterial Hand Sanitizer
77043-166-02	2022-01-28	C162847	48780-1	d6a99b39-576b-a426-e053-dadaa90af4c2	Antibacterial Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77043-166-01	Antibacterial Hand Sanitizer	500 mL in 1 BOTTLE, PLASTIC	LIQUID	500		1
77043-166-02	Antibacterial Hand Sanitizer	236 mL in 1 BOTTLE, PLASTIC	LIQUID	236		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77043-166	ANTIBACTERIAL HAND SANITIZER (ETHYL ALCOHOL) LIQUID [ROYAL DELUXE ACCESSORIES LLC]	1	Legacy NDC, 2 package rows	20200508_6a2ec96d-1ba5-4cad-9f6d-e5c7848511d6.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Antibacterial Hand Sanitizer
Ethyl Alcohol
ALCOHOL
WATER
GLYCERIN
PROPYLENE GLYCOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
FD&C YELLOW NO. 5
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77043-166	77043-166-02, 77043-166-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
TROLAMINE	9O3K93S3TK	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML · Source PDF

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
53ec7985-0d14-4533-8774-60f2663e5b88			6a2ec96d-1ba5-4cad-9f6d-e5c7848511d6	2020-04-28	Warnings	Exact identifier spl id: 53ec7985-0d14-4533-8774-60f2663e5b88 spl set id: 6a2ec96d-1ba5-4cad-9f6d-e5c7848511d6

Reported adverse events (FAERS/openFDA)#

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