NOWAVE HAND SANITIZER: Package Insert and Label Information

NOWAVE HAND SANITIZER- alcohol gel
NOWAVE LLC

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.

Drug Facts Active ingredient[s] Purpose Alcohol 80% v/v.………………………………………….………….……….….……………………………………………………………………………………..Antiseptic Use[s] Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. 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 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. Directions • Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing. Other information • Store between 15-30C (59-86F) • Avoid freezing and excessive heat above 40C (104F) Inactive ingredients glycerin, hydrogen peroxide, purified water USP

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

Alcohol 80% v/v …………Anitseptic

Do not use
in children less than 2 months of age
on open skin wounds

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. this may be a sign of a serious condition.

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

Glycerin, hydrogen peroxide, purified water USP

Use(s)

Hand sanitizer to help reduce bacteria that can cause disease. For use when soap and water are not available.

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions
place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise Children under 6 years of age to prevent swallowing.

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution [Insert Volume of Product in mL

NOWAVE HAND SANITIZER hand sanitizer gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74036-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 48 mL in 60 mL

Inactive Ingredients Ingredient Name Strength HYDROGEN PEROXIDE 0.075 mL in 60 mL GLYCERIN 0.87 mL in 60 mL WATER 11.12 mL in 60 mL

Product Characteristics Color white (clear) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:74036-001-02 60 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/27/2020

Labeler — NOWAVE LLC (112797757)

Registrant — NOWAVE LLC (822815047)

Establishment
Name	Address	ID/FEI	Operations
NOWAVE LLC		112797757	manufacture (74036-001)

Revised: 03/2020 NOWAVE LLC