Germy Gone Hand Sanitizer: Package Insert and Label Information

GERMY GONE HAND SANITIZER- alcohol gel
GERMY GONE 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

Alcohol 70% 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 15o-30^o C (59^o -86^o F)
• Avoid freezing and excessive heat above 40^o C (104^o F)

Inactive ingredients

glycerin, isopropyl myristate, methacrylic acid, propylene glycol, purified water USP, tetrahydroxypropyl ethylenediamine, vitamin E

Product Label

GERMY GONE HAND SANITIZER alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79725-001 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 WATER .ALPHA.-TOCOPHEROL ACETATE DENATONIUM BENZOATE GLYCERIN ISOPROPYL MYRISTATE PROPYLENE GLYCOL METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (4500 MPA.S) TRIISOPROPANOLAMINE LINALOOL, (+)- FRAGRANCE LAVENDER & CHIA F-153480 CUMINYL ACETALDEHYDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:79725-001-01 18 mL in 1 PACKAGE None 2 NDC:79725-001-02 59 mL in 1 BOTTLE, PLASTIC None 3 NDC:79725-001-03 118 mL in 1 BOTTLE, PLASTIC None 4 NDC:79725-001-04 237 mL in 1 BOTTLE, PLASTIC None 5 NDC:79725-001-05 355 mL in 1 BOTTLE, PLASTIC None 6 NDC:79725-001-06 473 mL in 1 BOTTLE, PLASTIC None 7 NDC:79725-001-07 500 mL in 1 BOTTLE, PLASTIC None 8 NDC:79725-001-08 946 mL in 1 BOTTLE, PLASTIC None 9 NDC:79725-001-09 1000 mL in 1 BOTTLE, PLASTIC None 10 NDC:79725-001-10 3785 mL in 1 BOTTLE, PLASTIC None 11 NDC:79725-001-11 4000 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 07/10/2020

Labeler — GERMY GONE LLC (117581441)

Revised: 07/2020 GERMY GONE LLC