FDA Label for Aktive Multi Purpose Antibacterial
View Indications, Usage & Precautions
Aktive Multi Purpose Antibacterial Product Label
The following document was submitted to the FDA by the labeler of this product Hall Global Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- 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.
- Sterile distilled water or boiled cold water.
- 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.
Otc - 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.
Otc - Stop Use
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
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
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