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

34oz
(click image for full-size original)
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

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