Spray

Manufacturer
Hall Global LLC
Effective date
2020-11-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:16

Label at a glance#

ProductAktive Multi Purpose Antibacterial
Active ingredientHYPOCHLOROUS ACID
Label structure13 sections

Dosage and administration

Adults and children 2 years and over: Spray on area and allow to dry without wiping. Children should be supervised when using and those under 2 years of age ask doctor before use. Discard empty bottle in trash receptacle.

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 Antibacterilal Spray 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 Antibacterilal Spray 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. Hypochlorous Acid (EPA Reg# 96048-1) (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. Sterile distilled water or boiled cold water.
  3. Sodium Chloride

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

Hypochlorous Acid (EPA Reg# 96048-1)

Purpose

OTC - PURPOSE SECTION

Sanitizing/Antimicrobial Agent Solution is on the EPA N-List N-Product with Emerging Viral Pathogens and Human Coronavirus claims for use against SARS CoV-2

Use

INDICATIONS & USAGE SECTION

Decreases bacteria on skin.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

If you are allergic to the ingredient. Avoid contact to the eyes and skin. May irritate eyes or sensitive skin. If contact occurs rinse thoroughly with water.

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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hrs

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

Adults and children 2 years and over: Spray on area and allow to dry without wiping. Children should be supervised when using and those under 2 years of age ask doctor before use. Discard empty bottle in trash receptacle.

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

purified water, Sodium Clhoride

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label printable display panelpackage label printable display panel000 mL NDC: 00000-000-00

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81156-002-082022-01-28C16284748780-1d6a99b3a-0033-a426-e053-dadaa90af4c2Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81156-002-08Aktive Multi Purpose Antibacterial236 mg in 1 BOTTLE, SPRAYLIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81156-002AKTIVE MULTI PURPOSE ANTIBACTERIAL (HYPOCHLOROUS ACID) LIQUID [HALL GLOBAL LLC]1Legacy NDC, 1 package rows20201126_b4e1c0d6-4a38-2fe9-e053-2995a90a12af.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81156-00281156-002-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
HYPOCHLOROUS ACID712K4CDC10ACTIB

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
b4e1f831-57ba-1845-e053-2995a90a8a18b4e1c0d6-4a38-2fe9-e053-2995a90a12af2020-11-24WarningsExact identifier
spl id: b4e1f831-57ba-1845-e053-2995a90a8a18
spl set id: b4e1c0d6-4a38-2fe9-e053-2995a90a12af

Reported adverse events (FAERS/openFDA)#

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