ALCOHOL BASED HAND SANITIZER TOTAL PURE

Manufacturer
BOTANICALS INTERNACIONAL S.A. DE C.V.
Effective date
2020-06-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:04

Label at a glance#

ProductALCOHOL BASED HAND SANITIZER TOTAL PURE
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

Directions • Place enough product in your palm to cover hands and rub hands together briskly until dry. • Children under 6 years of age should be surpervised when using this product.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

PURPOSE

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Carbomer, Triethanolamine. and Glycerine

KEEP OUT OF REACH SECTION

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

Directions

• Place enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be surpervised when using this product.

When using this product

OTC - WHEN USING SECTION

When using this product

Do not use near or in the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

WARNINGS

WARNINGS SECTION

Flammable

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ML NDC: 51384-003-002

500ML FRONT LABEL500ML FRONT LABEL

LabelLabel

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51384-003-01ALCOHOL BASED HAND SANITIZER TOTAL PURE1000 mL in 1 BOTTLEGEL10003
51384-003-02ALCOHOL BASED HAND SANITIZER TOTAL PURE500 mL in 1 BOTTLEGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51384-003ALCOHOL BASED HAND SANITIZER TOTAL PURE (HAND SANITIZER) GEL [BOTANICALS INTERNACIONAL S.A. DE C.V.]3Legacy NDC, 2 package rows20200618_a6147052-04cd-33ce-e053-2995a90a6998.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
51384-00351384-003-01, 51384-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
a84fbd1a-ec1e-56b7-e053-2a95a90aeb2aa6147052-04cd-33ce-e053-2995a90a69982020-06-17WarningsExact identifier
spl id: a84fbd1a-ec1e-56b7-e053-2a95a90aeb2a
spl set id: a6147052-04cd-33ce-e053-2995a90a6998

Reported adverse events (FAERS/openFDA)#

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