BotaniClean

Manufacturer
LYR FARMACEUTICA LTDA
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:55

Label at a glance#

ProductBotaniClean
Active ingredientALCOHOL
Label structure6 sections

Indications and uses

Hand sanitizer to help decrease bacteria on the skin when water, soap & towels are not available. Recommended for repeated use.

Dosage and administration

Press the valve twice on to your hands, briskly rub hands together covering the area to be disinfected, following the protocol defined by your organization or your physician. Let it dry, do not rinse or dry with a towel or paper towel.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 69.9%

Purpose

OTC - PURPOSE SECTION

Antiseptic

USES

USE IN SPECIFIC POPULATIONS SECTION

Hand sanitizer to help decrease bacteria on the skin when water, soap & towels are not available. Recommended for repeated use.

WARNINGS

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes. In case of contact flush eyes with abundant water.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if unfavorable reaction occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. children must be supervised in use of this product.

OTC - DO NOT USE SECTION

Do not use on the face.

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

Press the valve twice on to your hands, briskly rub hands together covering the area to be disinfected, following the protocol defined by your organization or your physician. Let it dry, do not rinse or dry with a towel or paper towel.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (aqua), Glycerin, Carbomer, Triethanolamine, Aloe Barbadense Leaf
Water (Aloe Vera)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug FactsDrug Facts

Product NameProduct Name

300 mL NDC: 78934-319-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78934-319-032022-01-28C16284748780-1d6a99b39-dc42-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78934-319-03BotaniClean300 mL in 1 BOTTLE, PUMPLIQUID3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78934-319BOTANICLEAN (HAND SANITIZER) LIQUID [LYR FARMACEUTICA LTDA]11 package rows20200617_a7a948c5-353b-b5c7-e053-2995a90a2f33.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78934-31978934-319-03

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
a7a948c5-353c-b5c7-e053-2995a90a2f33a7a948c5-353b-b5c7-e053-2995a90a2f332020-06-09WarningsExact identifier
spl id: a7a948c5-353c-b5c7-e053-2995a90a2f33
spl set id: a7a948c5-353b-b5c7-e053-2995a90a2f33

Reported adverse events (FAERS/openFDA)#

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