CUBRE T ® HAND SANITIZER GEL

Manufacturer: Frozen Wheels, Llc
Effective date: 2020-07-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:20:54

Label at a glance#

ProductCUBRETE ANTISEPTIC HAND SANITIZER

Active ingredientALCOHOL

Label structure11 sections

Indications and uses

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

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly untill dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

• Store below 110°F (43°C) • May discolor certain fabrics

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Flammable

• Keep away from fire or flame. • For external use only.

When using this product

• Do not use it in or near the eyes. • In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if skin irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help in a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Put enough product in your palm to cover hands and rub hands together briskly untill dry.
Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

• Store below 110°F (43°C) • May discolor certain fabrics

INACTIVE INGREDIENT SECTION

Inactive Ingredients Triethanolamine, Carbomer, Polysorbate, Water, Glycerin.

Questions?

OTC - QUESTIONS SECTION

+52 1 56 1876 7678 info@cubret.mx

SPL UNCLASSIFIED SECTION

Alcohol Based

Manufactured by: Corporativo Cubrete, S.A. de C.V. Calzada las Aguilas 1709, Interior B, Lomas de Guadalupe, Alvaro Obregon, C.P.01720 Made in Mexio

Imported by: Frozen Wheels, LLC 16565 NW 15th Ave. Miami, FL 33169

HECHO EN

MEXICO

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitled

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitled

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77031-105-01	2022-01-28	C162847	48780-1	d6a99b39-dd75-a426-e053-dadaa90af4c2	CUBRE T ® HAND SANITIZER GEL
77031-105-02	2022-01-28	C162847	48780-1	d6a99b39-dd75-a426-e053-dadaa90af4c2	CUBRE T ® HAND SANITIZER GEL
77031-105-04	2022-01-28	C162847	48780-1	d6a99b39-dd75-a426-e053-dadaa90af4c2	CUBRE T ® HAND SANITIZER GEL
77031-105-08	2022-01-28	C162847	48780-1	d6a99b39-dd75-a426-e053-dadaa90af4c2	CUBRE T ® HAND SANITIZER GEL
77031-105-16	2022-01-28	C162847	48780-1	d6a99b39-dd75-a426-e053-dadaa90af4c2	CUBRE T ® HAND SANITIZER GEL
77031-105-33	2022-01-28	C162847	48780-1	d6a99b39-dd75-a426-e053-dadaa90af4c2	CUBRE T ® HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77031-105-01	CUBRETE ANTISEPTIC HAND SANITIZER	4000 mL in 1 BOTTLE, PLASTIC	GEL	4000	1
77031-105-02	CUBRETE ANTISEPTIC HAND SANITIZER	50 mL in 1 BOTTLE, PLASTIC	GEL	50	1
77031-105-04	CUBRETE ANTISEPTIC HAND SANITIZER	125 mL in 1 BOTTLE, PLASTIC	GEL	125	1
77031-105-08	CUBRETE ANTISEPTIC HAND SANITIZER	250 mL in 1 BOTTLE, PLASTIC	GEL	250	1
77031-105-16	CUBRETE ANTISEPTIC HAND SANITIZER	500 mL in 1 BOTTLE, PLASTIC	GEL	500	1
77031-105-33	CUBRETE ANTISEPTIC HAND SANITIZER	1000 mL in 1 BOTTLE, PLASTIC	GEL	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77031-105	CUBRETE ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [FROZEN WHEELS, LLC]	1	Legacy NDC, 6 package rows	20200711_0e63e35a-a21a-4939-abbd-7d88fc877ef9.zip

Products#

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

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

CUBRETE ANTISEPTIC HAND SANITIZER
Ethyl alcohol
ALCOHOL
TROLAMINE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
POLYSORBATE 20
WATER
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77031-105	77031-105-02, 77031-105-04, 77031-105-08, 77031-105-16, 77031-105-33, 77031-105-01

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
ALCOHOL	3K9958V90M	ACTIB
TROLAMINE	9O3K93S3TK	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	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
22dc820f-494c-4ec7-9148-5a80b01130ce			0e63e35a-a21a-4939-abbd-7d88fc877ef9	2020-07-08	Warnings	Exact identifier spl id: 22dc820f-494c-4ec7-9148-5a80b01130ce spl set id: 0e63e35a-a21a-4939-abbd-7d88fc877ef9

Reported adverse events (FAERS/openFDA)#

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