AKTIVE MULTI PURPOSE ANTIBACTERIAL- hypochlorous acid liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)
Available from:
Hall Global LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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 Decreases bacteria on skin. 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. Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hrs
Authorization status:
unapproved drug other
Authorization number:
81156-002-08

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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:

a. 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.

b. Sterile distilled water or boiled cold water.

c. 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)

Purpos e

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

Us e

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

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

AKTIVE MULTI PURPOSE ANTIBACTERIAL

hypochlorous acid liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 1156 -0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYPO CHLO RO US ACID (UNII: 712K4CDC10 ) (HYPOCHLOROUS ACID -

UNII:712K4CDC10 )

HYPOCHLOROUS

ACID

0 .25 mg

in 10 0 mg

Hall Global LLC

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

3.0 5 mg in 10 0 mg

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 1156 -0 0 2-

236 mg in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/30 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 3/30 /20 20

Labeler -

Hall Global LLC (117729725)

Registrant -

Hall Global LLC (117729725)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hall Glo bal LLC

117729 725

ma nufa c ture (8 1156 -0 0 2)

Revised: 11/2020

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