FDA.reportPublic FDA data

NATURAL

Manufacturer
INTERNATIONAL GENERAL TRADING CORP | House and Beauty Care México, S.A. de C.V.
Effective date
2020-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:12

Label at a glance#

ProductNATURAL
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Wash hands, apply palful to hhand rub thoughly and rinse

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

FOR HANDWASHING TO DECREASE BATERIA ON THE SKIN

Warnings

WARNINGS SECTION

For external use only.

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 do not get into yes. If contact occurs rinse eye throughly with water

OTC - STOP USE SECTION

stop use and ask a docor if irritation or redness develops

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

Wash hands, apply palful to hhand rub thoughly and rinse

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, SODIUM LAURYLETHER SULFATHEM COCOAMIDO PROPYL, BETAINE, GLYCERIN, ESSENTIAL OILS, SODIUM CHORIDE, COLLAGEN. SODIUMFEINT, SALT, ALOE VERA, YELLOW#5 d&c, RED#4 D&C

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABELSOAPSOAP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78440-001-012022-01-28C16284748780-1d6a99b39-f768-a426-e053-dadaa90af4c2NATURAL CARE ANTIBACTERIAL
78440-001-022022-01-28C16284748780-1d6a99b39-f768-a426-e053-dadaa90af4c2NATURAL CARE ANTIBACTERIAL
78440-001-032022-01-28C16284748780-1d6a99b39-f768-a426-e053-dadaa90af4c2NATURAL CARE ANTIBACTERIAL
78440-001-042022-01-28C16284748780-1d6a99b39-f768-a426-e053-dadaa90af4c2NATURAL CARE ANTIBACTERIAL
78440-001-052022-01-28C16284748780-1d6a99b39-f768-a426-e053-dadaa90af4c2NATURAL CARE ANTIBACTERIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78440-001-01NATURAL1892 mL in 1 BOTTLEGEL18921
78440-001-02NATURAL236 mL in 1 BOTTLEGEL2361
78440-001-03NATURAL3785 mL in 1 BOTTLEGEL37851
78440-001-04NATURAL118 mL in 1 BOTTLEGEL1181
78440-001-05NATURAL1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78440-001NATURAL (ANTIBACTERIAL) GEL [INTERNATIONAL GENERAL TRADING CORP]1Legacy NDC, 5 package rows20200714_aa52eac4-5178-86c8-e053-2995a90a8f9f.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78440-00178440-001-01, 78440-001-03, 78440-001-02, 78440-001-04, 78440-001-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
aa52eac4-516a-86c8-e053-2995a90a8f9faa52eac4-5178-86c8-e053-2995a90a8f9f2020-07-13WarningsExact identifier
spl id: aa52eac4-516a-86c8-e053-2995a90a8f9f
spl set id: aa52eac4-5178-86c8-e053-2995a90a8f9f

Reported adverse events (FAERS/openFDA)#

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