OTC Medication Information: Hand Sanitizer

HAND SANITIZER- alcohol gel
Pure Humanity, 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.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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.

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

Water, Carbomer 940, Glycerin, Hydrogen Peroxide, Trolamine, Linalool, Lavender Oil (Fragrance)

​3785mL NDC: 79411-001-01

HAND SANITIZER alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79411-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength CARBOMER 940 TROLAMINE LINALOOL, (+)- LAVENDER OIL GLYCERIN HYDROGEN PEROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:79411-001-01 3785 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/29/2020

Labeler — Pure Humanity, LLC (109805816)

Revised: 07/2020 Pure Humanity, LLC