IBARRA

Manufacturer: PROMAQUILA DE COCULA, S.A. DE C.V.
Effective date: 2020-08-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:23:47

Label at a glance#

ProductIBARRA

Active ingredientALCOHOL

Label structure10 sections

Indications and uses

Use[s] Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Directions Place enough product on hands to cover all surfaces. Rub hands together until dry.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient. Ethyl Alcohol 70%

PURPOSE

OTC - PURPOSE SECTION

Purpose Antmicrobial

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Use[s]

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Store below 110°F (43°C)

Children under 6 years of age should be supervised when using.

WARNINGS

WARNINGS SECTION

Warnings

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

STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INCTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Glycerin, Carbomer, Triethanolamine, Aloe Vera Leaf, Menthol

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 250 mL with mentholLABEL 500 mL with mentholLABEL 1000 mL with menthol

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79577-0003-3	2022-01-28	C162847	48780-1	d6a99b39-c6b3-a426-e053-dadaa90af4c2	MENTHOL SCENTED HAND SANITIZER
79577-0003-4	2022-01-28	C162847	48780-1	d6a99b39-c6b3-a426-e053-dadaa90af4c2	MENTHOL SCENTED HAND SANITIZER
79577-0003-5	2022-01-28	C162847	48780-1	d6a99b39-c6b3-a426-e053-dadaa90af4c2	MENTHOL SCENTED HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
79577-0003-3	IBARRA	250 mL in 1 BOTTLE	GEL	250	2
79577-0003-4	IBARRA	500 mL in 1 BOTTLE	GEL	500	2
79577-0003-5	IBARRA	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
79577-0003	IBARRA (ALCOHOL) GEL [PROMAQUILA DE COCULA, S.A. DE C.V.]	2	Legacy NDC, 3 package rows	20200805_ac070d5b-a217-6bc9-e053-2995a90a9805.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

IBARRA
ALCOHOL
WATER
GLYCERIN
AMINOMETHYLPROPANOL
ALOE VERA LEAF
MENTHOL
CARBOMER 940

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79577-0003	79577-0003-3, 79577-0003-4, 79577-0003-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
ALCOHOL	3K9958V90M	ACTIB
MENTHOL	L7T10EIP3A	IACT
CARBOMER 940	4Q93RCW27E	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
ac15449e-f995-4343-e053-2a95a90a7cbf			ac070d5b-a217-6bc9-e053-2995a90a9805	2020-08-04	Warnings	Exact identifier spl id: ac15449e-f995-4343-e053-2a95a90a7cbf spl set id: ac070d5b-a217-6bc9-e053-2995a90a9805

Reported adverse events (FAERS/openFDA)#

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