B CLEAN HAND SANITIZER

Manufacturer
HETH LLC | AGE DO BRASIL INDUSTRIA E COMERCIO LTDA.
Effective date
2020-08-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:24:07

Label at a glance#

ProductB CLEAN HAND SANITIZER
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.

Storage and handling

Store between 59º-86ºF (15º-30ºC) Avoid freezing and excessive heat above 104ºF (40ºC) May discolor certain fabrics

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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

  • 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 59º-86ºF (15º-30ºC)
  • Avoid freezing and excessive heat above 104ºF (40ºC)
  • May discolor certain fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Carbomer, Denatonium Benzoate, Isopropanolamine, Mentha Piperita Extract, Propylene Glycol, Salvia Officinalis Leaf Extract, Verbena Officinalis Leaf Extract

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

B CLEAN

HAND SANITIZER
ALCOHOL-BASED GEL

moisturizing
alcohol 75%

Manufactured by: Age do
Brasil Ind. e Com. LTDA.
Vinhedo SP
CEP 13288-169
Brazil

Distributed by: Heth LLC
7522 Campbell Road
Suite 113 #272
Dallas TX 75248
+1 844 989 3111

MADE IN BRAZIL

Warning! Flammable liquid and vapor

NDC 78310-101-04NDC 78310-101-04NDC 78310-101-03NDC 78310-101-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78310-101-03B CLEAN HAND SANITIZER440 g in 1 BOTTLEGEL4403
78310-101-04B CLEAN HAND SANITIZER440 g in 1 BOTTLE, PUMPGEL4403
78310-101-05B CLEAN HAND SANITIZER1320 g in 1 KITGEL13203
78310-101-06B CLEAN HAND SANITIZER1320 g in 1 KITGEL13203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78310-101B CLEAN HAND SANITIZER (ETHYL ALCOHOL) GEL [HETH LLC]3Legacy NDC, 4 package rows20200808_a70ce788-4c01-3e6d-e053-2995a90a2ee7.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78310-10178310-101-03, 78310-101-04, 78310-101-05, 78310-101-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ac4fa1c7-6456-48d3-e053-2a95a90a832aa70ce788-4c01-3e6d-e053-2995a90a2ee72020-08-07WarningsExact identifier
spl id: ac4fa1c7-6456-48d3-e053-2a95a90a832a
spl set id: a70ce788-4c01-3e6d-e053-2995a90a2ee7

Reported adverse events (FAERS/openFDA)#

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