FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
BOTANICALS INTERNACIONAL S.A. DE C.V | BOTANICALS INTERNACIONAL S.A. DE C.V.
Effective date
2020-06-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:04

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Use: hands sanitizer to help decrease bacteria on the skin

Dosage and administration

Direction : Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years old should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Keep out of reach of children

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.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Warnings

WARNINGS SECTION

Warnings

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

Directions

DOSAGE & ADMINISTRATION SECTION

Direction:

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

Uses

INDICATIONS & USAGE SECTION

Use: hands sanitizer to help decrease bacteria on the skin

Stop use and ask a doctor

OTC - STOP USE SECTION

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

When using this product

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients:

water 28%, glycerin 1%, carbopol 940 0.50%,TEA 85 0.50%,

Other information

SPL UNCLASSIFIED SECTION

Store below 110 oF (43 oC)

May discolor certain fabrics

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51384-002-01

LabelLabelLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51384-002-01HAND SANITIZER900 mL in 1 BOTTLEGEL9002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51384-002HAND SANITIZER (ETHANOL) GEL [BOTANICALS INTERNACIONAL S.A. DE C.V]2Legacy NDC, 1 package rows20200618_a4e9c9d8-e9ec-1550-e053-2995a90a300d.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
51384-00251384-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
a850c1a3-8e1a-501b-e053-2995a90a445ba4e9c9d8-e9ec-1550-e053-2995a90a300d2020-06-17WarningsExact identifier
spl id: a850c1a3-8e1a-501b-e053-2995a90a445b
spl set id: a4e9c9d8-e9ec-1550-e053-2995a90a300d

Reported adverse events (FAERS/openFDA)#

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