Biorell

Manufacturer
Chaptec Inc
Effective date
2020-09-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:25

Label at a glance#

ProductBiorell
Active ingredientALCOHOL
Label structure10 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 59 - 86 °F (15 - 30 °C). Avoid freezing and excessive heat above 104 °F (40 °C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70 % v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

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.

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 59 - 86 °F (15 - 30 °C).
  • Avoid freezing and excessive heat above 104 °F (40 °C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, fragrance, glycerin, isopropyl alcohol, trolamine, water.

Questions or comments?

OTC - QUESTIONS SECTION

1 514 498-3620

Monday to Friday, 8:30 a.m.- 4:30 p.m.

PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Odor of Green Apple
Biorell

Hand Sanitizer

Non-sterile
Solution

Alcohol Antiseptic 70%
Topical Solution

Net Content
3.78 L

PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label
PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79738-001-012022-01-28C16284748780-1d6a99b39-fb98-a426-e053-dadaa90af4c2Biorell
79738-001-022022-01-28C16284748780-1d6a99b39-fb98-a426-e053-dadaa90af4c2Biorell
79738-001-032022-01-28C16284748780-1d6a99b39-fb98-a426-e053-dadaa90af4c2Biorell
79738-001-042022-01-28C16284748780-1d6a99b39-fb98-a426-e053-dadaa90af4c2Biorell
79738-001-052022-01-28C16284748780-1d6a99b39-fb98-a426-e053-dadaa90af4c2Biorell

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79738-001-01Biorell118 mL in 1 BOTTLEGEL1181
79738-001-02Biorell250 mL in 1 BOTTLEGEL2501
79738-001-03Biorell500 mL in 1 BOTTLEGEL5001
79738-001-04Biorell1000 mL in 1 BOTTLEGEL10001
79738-001-05Biorell3780 mL in 1 BOTTLEGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79738-001BIORELL (ALCOHOL) GEL [CHAPTEC INC]1Legacy NDC, 5 package rows20200916_a46ec72f-6337-4142-966f-a8a5753d56d3.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79738-00179738-001-01, 79738-001-02, 79738-001-03, 79738-001-04, 79738-001-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
bd402a0d-d63a-4481-8a6a-9da9d94b5efaa46ec72f-6337-4142-966f-a8a5753d56d32020-09-11WarningsExact identifier
spl id: bd402a0d-d63a-4481-8a6a-9da9d94b5efa
spl set id: a46ec72f-6337-4142-966f-a8a5753d56d3

Reported adverse events (FAERS/openFDA)#

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