Calidad Premium Fresh Gel Antibacterial

Manufacturer: Distribuidora de Sistemas Didacticos , S.A. de C.V.
Effective date: 2022-09-14
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:50:40

Label at a glance#

ProductCalidad Premium Fresh Antibacterial

Active ingredientALCOHOL

Label structure8 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.

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Distilled Water, Glycerin, Carbomer, Triethanolamine, EDTA, Without fragrance.

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

OTC - DO NOT USE SECTION

IN CHILDREN LESS THAN 2 MONTHS OF AGE
ON OPEN SKIN WOUNDS

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a 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.

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

SPL UNCLASSIFIED SECTION

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

Questions or Comments:

OTC - QUESTIONS SECTION

52 (55) 3686-0416 / 52 (55) 4741-7431 direccion@distribuidoradesistemas.com.mx

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581662	ethanol 70 % Topical Gel	PSN	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	2
581662	ethanol 70 % Topical Gel	SY	2
581662	ethyl alcohol 70 % Topical Gel	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79728-000-01	2023-07-28	C162847	48780-1	d6a99b39-782b-a426-e053-dadaa90af4c2	Calidad Premium Fresh Gel Antibacterial
79728-000-01	2022-09-14	C162847	48780-1	d6a99b39-782b-a426-e053-dadaa90af4c2	Calidad Premium Fresh Gel Antibacterial
79728-000-01	2022-01-28	C162847	48780-1	d6a99b39-782b-a426-e053-dadaa90af4c2	Calidad Premium Fresh Gel Antibacterial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79728-000-01	Calidad Premium Fresh Antibacterial	1000 mL in 1 BOTTLE	GEL	1000		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79728-000	CALIDAD PREMIUM FRESH ANTIBACTERIAL (ALCOHOL) GEL [DISTRIBUIDORA DE SISTEMAS DIDACTICOS , S.A. DE C.V.]	2	Legacy NDC, 1 package rows	20220916_8a7f386f-7ceb-403f-bf61-69a0c8e204f1.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Calidad Premium Fresh Antibacterial
ALCOHOL
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
EDETIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79728-000	79728-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
TROLAMINE	9O3K93S3TK	IACT
EDETIC ACID	9G34HU7RV0	IACT
ALCOHOL	3K9958V90M	ACTIB

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
e8a32e53-3f64-5340-e053-2a95a90ad7af			8a7f386f-7ceb-403f-bf61-69a0c8e204f1	2022-09-14	Warnings	Exact identifier spl id: e8a32e53-3f64-5340-e053-2a95a90ad7af spl set id: 8a7f386f-7ceb-403f-bf61-69a0c8e204f1

Reported adverse events (FAERS/openFDA)#

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