Hand Sanitizer

Manufacturer: Roqueplast, S.A. de C.V.
Effective date: 2020-01-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:04:54

Label at a glance#

ProductHand Sanitizer

Active ingredientALCOHOL

Label structure12 sections

Indications and uses

■ For hand washing to decrease bacteria on the skin and ■ Recommended for daily and repeated use.

Dosage and administration

■ Wet hands throughhly with product, briskly rub hands together until they are dry. ■ Supervise children in the use of this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ For hand washing to decrease bacteria on the skin and ■ Recommended for daily and repeated use.

Warnings

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

■ do not use in the eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ irritation and redness develop and persist for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Wet hands throughhly with product, briskly rub hands together until they are dry. ■ Supervise children in the use of this product.

Other information

SPL UNCLASSIFIED SECTION

■ Store below 105ºF

■ May discolor some fabrics

Other information

SPL UNCLASSIFIED SECTION

■ Store at 20º-25º C (68º to 72º F) ■ may discolor certain fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

distilled water, carbopol, triethanolamine, glycerin

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50058-100-08	2022-01-28	C162847	48780-1	d6a99b39-d5f7-a426-e053-dadaa90af4c2	Command Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50058-100-08	Hand Sanitizer	250 mL in 1 BOTTLE, PLASTIC	GEL	250		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50058-100	HAND SANITIZER (ALCOHOL) GEL [ROQUEPLAST, S.A. DE C.V.]	1	Legacy NDC, 1 package rows	20200404_9c5c0609-a588-b264-e053-2995a90a2c32.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Hand Sanitizer
Alcohol
GLYCERIN
TROLAMINE
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50058-100	50058-100-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	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
9c5c8368-7851-4cac-e053-2a95a90a2733			9c5c0609-a588-b264-e053-2995a90a2c32	2020-01-16	Warnings	Exact identifier spl id: 9c5c8368-7851-4cac-e053-2a95a90a2733 spl set id: 9c5c0609-a588-b264-e053-2995a90a2c32

Reported adverse events (FAERS/openFDA)#

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