Defense AG Disinfectant: Package Insert and Label Information

DEFENSE AG DISINFECTANT- hydrogen peroxide and alcohol spray
Nexderma

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic to help reduce bacteria that potentially can cause disease.

Hydrogen Peroxide

Inactive ingredients

ultra pure water, Nano Silver Ag+

Use

To clean and remove allergens, wipe surfaces clean with product and let dry. Can use on porous surfaces. Kills 99.99% of germs around the home, office and classroom.

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

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

Directions

• Spray enough product to cover all surfaces. Wipe clean and let it dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Purpose

Antiseptic to help reduce bacteria that potentially can cause disease.

Package Label — Principal Display Panel

946 mL NDC: 79930-7116-6

3790 mL NDC: 79930-7116-5

DEFENSE AG DISINFECTANT ea disinfectant spray spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79930-7116 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE 0.125 mL in 100 mL ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL

Inactive Ingredients Ingredient Name Strength SILVER 0.2 mL in 100 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:79930-7116-4 473 mL in 1 BOTTLE, SPRAY None 2 NDC:79930-7116-6 946 mL in 1 BOTTLE, SPRAY None 3 NDC:79930-7116-5 3790 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/09/2020

Labeler — Nexderma (079533940)

Establishment
Name	Address	ID/FEI	Operations
Nexderma		079533940	manufacture (79930-7116), pack (79930-7116), label (79930-7116)

Revised: 11/2020 Nexderma