AKTIVE MULTI PURPOSE ANTIBACTERIAL- hypochlorous acid liquid

Aktive Multi Purpose Antibacterial by

Drug Labeling and Warnings

Aktive Multi Purpose Antibacterial by is a Otc medication manufactured, distributed, or labeled by Hall Global LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

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

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

KEEP OUT OF REACH OF CHILDREN

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

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

Inactive ingredients

purified water, Sodium Clhoride

Package Label - Principal Display Panel

000 mL NDC: 00000-000-00

INGREDIENTS AND APPEARANCE

AKTIVE MULTI PURPOSE ANTIBACTERIAL 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81156-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.25 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	3.05 mg  in 100 mg
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81156-002-08	236 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2020

Labeler - Hall Global LLC (117729725)

Registrant - Hall Global LLC (117729725)

Establishment
Name	Address	ID/FEI	Business Operations
Hall Global LLC		117729725	manufacture(81156-002)