Unscented Hand Sanitizer: Package Insert and Label Information

UNSCENTED HAND SANITIZER- isopropyl alcohol spray
Plant Therapy, 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

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

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.

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°- 30°C (59°- 86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

ESSENTIAL OILS

TOPICAL SOLUTION

99.9% effective against most common germs

For more information, visit

PlantTherapy.com

800-917-6577

Made in USA

Manufactured by: Plant Therapy, LLC | Twin Falls, ID 83301

Packaging

UNSCENTED HAND SANITIZER isopropyl alcohol spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74877-110 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength GLYCERIN HYDROGEN PEROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:74877-110-02 100 mL in 1 BOTTLE, GLASS None 2 NDC:74877-110-01 237 mL in 1 BOTTLE, SPRAY None 3 NDC:74877-110-03 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 04/20/2020

Labeler — Plant Therapy, LLC (080128261)

Establishment
Name	Address	ID/FEI	Operations
Plant Therapy, LLC		080128261	manufacture (74877-110)

Revised: 04/2020 Plant Therapy, LLC