GelMex Black

Manufacturer: Grupo Siller Ingeniería Construcción y Materiales, S.A. de C.V
Effective date: 2020-09-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:28:48

Label at a glance#

ProductGelMex Black

Active ingredientALCOHOL

Label structure9 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80%v/v

Purposes

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.

Warnings

WARNINGS SECTION

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

Do not mix use with other household chemicals.

Do not use

In children less than two 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 throughly with water.

Stop use and ask a doctor if irritation or rash occurs. These maybe sings of serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

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

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SPL UNCLASSIFIED SECTION

Store between 15-30°C (59-86°F)
Avoid freezing and excesive heat above 400°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, carbomer 940, aloe vera extract, purified water.

Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1041498	ethanol 80 % Topical Gel	PSN	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	1
1041498	ethanol 80 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80308-001-01	2022-01-28	C162847	48780-1	d6a99b39-7b54-a426-e053-dadaa90af4c2	GelMex Black
80308-001-02	2022-01-28	C162847	48780-1	d6a99b39-7b54-a426-e053-dadaa90af4c2	GelMex Black
80308-001-03	2022-01-28	C162847	48780-1	d6a99b39-7b54-a426-e053-dadaa90af4c2	GelMex Black

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80308-001-01	GelMex Black	5 mL in 1 POUCH	GEL	5	1
80308-001-02	GelMex Black	250 mL in 1 BOTTLE, PLASTIC	GEL	250	1
80308-001-03	GelMex Black	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
80308-001	GELMEX BLACK (ALCOHOL) GEL [GRUPO SILLER INGENIER&IACUTE;A CONSTRUCCI&OACUTE;N Y MATERIALES, S.A. DE C.V]	1	Legacy NDC, 3 package rows	20200909_f429dd54-fe38-4fa0-9a10-b85040f9b17d.zip

Products#

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

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

GelMex Black
Alcohol
WATER
GLYCERIN
CARBOMER 940
ALOE VERA LEAF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80308-001	80308-001-01, 80308-001-02, 80308-001-03

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
ALCOHOL	3K9958V90M	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER 940	4Q93RCW27E	IACT
ALOE VERA LEAF	ZY81Z83H0X	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
57cf4121-aaeb-48fe-9b0b-d555856d88b4			f429dd54-fe38-4fa0-9a10-b85040f9b17d	2020-09-04	Warnings	Exact identifier spl id: 57cf4121-aaeb-48fe-9b0b-d555856d88b4 spl set id: f429dd54-fe38-4fa0-9a10-b85040f9b17d

Reported adverse events (FAERS/openFDA)#

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