AKTIVE MULTI PURPOSE ANTIBACTERIAL- hypochlorous acid liquid 
Hall Global LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Spray

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)

Hypochlorous Acid (EPA Reg# 96048-1)

Purpose

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

Decreases bacteria on skin.

Warnings

For external use only.

Do not use

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.

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.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Inactive ingredients

purified water, Sodium Clhoride

Package Label - Principal Display Panel

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

AKTIVE MULTI PURPOSE ANTIBACTERIAL 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81156-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.25 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.05 mg  in 100 mg
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81156-002-08236 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/30/2020
Labeler - Hall Global LLC (117729725)
Registrant - Hall Global LLC (117729725)
Establishment
NameAddressID/FEIBusiness Operations
Hall Global LLC117729725manufacture(81156-002)

Revised: 11/2020
Document Id: b4e1f831-57ba-1845-e053-2995a90a8a18
Set id: b4e1c0d6-4a38-2fe9-e053-2995a90a12af
Version: 1
Effective Time: 20201124
 
Hall Global LLC