NUBAAL Alcohol Antiseptic 80 Topical Antiseptic Hand Rub Non-sterile

Manufacturer: Botanicals Internacional S.A. de C.V.
Effective date: 2020-06-19
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:18:23

Label at a glance#

ProductNUBAAL Alcohol Antiseptic 80 Topical Antiseptic Hand Rub Non-sterile

Active ingredientALCOHOL

Label structure7 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.

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (s)

OTC - ACTIVE INGREDIENT SECTION

Organic Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

Do not use

in children less than 2 months of age
on open skin wounds

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

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

STORAGE AND HANDLING SECTION

store between 15-30 ^oC (59-86 ^oF)
Avoid freezing and excessive heat above 40 ^oC (104 ^oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, hydrogen pyroxide, purified water, Aloe vera extract, sweet orange essential oil, tocopherol

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51384-001-01	NUBAAL Alcohol Antiseptic 80 Topical Antiseptic Hand Rub Non-sterile	350 mL in 1 BOTTLE	GEL	350		3
51384-001-02	NUBAAL Alcohol Antiseptic 80 Topical Antiseptic Hand Rub Non-sterile	118 mL in 1 BOTTLE	GEL	118		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51384-001	NUBAAL ALCOHOL ANTISEPTIC 80 TOPICAL ANTISEPTIC HAND RUB NON-STERILE (ALCOHOL) GEL [BOTANICALS INTERNACIONAL S.A. DE C.V.]	3	Legacy NDC, 2 package rows	20200620_a49a242e-b061-2598-e053-2995a90afdb7.zip

Products#

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

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

NUBAAL Alcohol Antiseptic 80 Topical Antiseptic Hand Rub Non-sterile
ALCOHOL
TOCOPHEROL
ORANGE OIL
WATER
GLYCERIN
HYDROGEN PEROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51384-001	51384-001-01, 51384-001-02

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
TOCOPHEROL	R0ZB2556P8	IACT
ORANGE OIL	AKN3KSD11B	IACT
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYDROGEN PEROXIDE	BBX060AN9V	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
a878b139-8998-e154-e053-2995a90a621e			a49a242e-b061-2598-e053-2995a90afdb7	2020-06-19	Warnings	Exact identifier spl id: a878b139-8998-e154-e053-2995a90a621e spl set id: a49a242e-b061-2598-e053-2995a90afdb7

Reported adverse events (FAERS/openFDA)#

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