Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- alcohol liquid
Atc Scientific, 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.

Hand Sanitizer — 12oz & 32oz

Front Label — 12oz:

Front Label — 32oz:

Back Label (all sizes):

Purpose

Antiseptic

Warnings

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

Warnings

For external use only. Keep away from heat or flame

Do not use in children less than 2 months of age

Do not use op 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.

Use(s)

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

Inactive Ingredients

glycerol, hydrogen peroxide, purified water USP

Directions & Other Information

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.

Store between 15-30C (59-86F)

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

Active Ingredient(s)

Isopropyl alcohol 75% v/v

HAND SANITIZER hand sanitizer liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74133-101 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL

Inactive Ingredients Ingredient Name Strength GLYCEROL FORMAL 1.45 mL in 100 mL HYDROGEN PEROXIDE 0.12 mL in 100 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:74133-101-01 354 mL in 1 BOTTLE, PLASTIC None 2 NDC:74133-101-02 946 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 part333A 03/27/2020

Labeler — Atc Scientific, LLC (801189015)

Registrant — Atc Scientific, LLC (801189015)

Establishment
Name	Address	ID/FEI	Operations
Atc Scientific, LLC		801189015	manufacture (74133-101)

Revised: 03/2020 Atc Scientific, LLC