NSD Hand Sanitizer: Package Insert and Label Information

NSD HAND SANITIZER- alcohol liquid
North Shore Distillery, 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.

Warnings:

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

Active Ingredient(s)

Active Ingredients ………….……….….…………………………………… Purpose

Alcohol 80% v/v…….………….……….….……………………………………Antiseptic

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.

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Other Information

• Store between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

Use(s)

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 when using this product to avoid swallowing.

Use(s)

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

NSD Hand Sanitizer

Non-sterile solution  For External Use Only  Alcohol Antiseptic 80% Topical Solution  northshoredistillery.com  89 ml (sample volume)
(click image for full-size original)

NSD HAND SANITIZER
hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73899-101
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
HYDROGEN PEROXIDE
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73899-101-02 59 mL in 1 BOTTLE, SPRAY None
2 NDC:73899-101-03 89 mL in 1 BOTTLE, DISPENSING None
3 NDC:73899-101-08 237 mL in 1 BOTTLE, GLASS None
4 NDC:73899-101-16 473 mL in 1 BOTTLE, GLASS None
5 NDC:73899-101-25 750 mL in 1 BOTTLE, GLASS None
6 NDC:73899-101-32 1000 mL in 1 BOTTLE, GLASS None
7 NDC:73899-101-34 1000 mL in 1 BOTTLE, PLASTIC None
8 NDC:73899-101-64 1892 mL in 1 BOTTLE, PLASTIC None
9 NDC:73899-101-28 3785 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/21/2020
Labeler — North Shore Distillery, LLC (056586695)
Registrant — North Shore Distillery, LLC (056586695)
Establishment
Name Address ID/FEI Operations
North Shore Distillery, LLC 056586695 manufacture (73899-101)

Revised: 03/2020 North Shore Distillery, LLC

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