RCD Hand Sanitizer: Package Insert and Label Information

RCD HAND SANITIZER- alcohol liquid
Rush Creek Distilling, 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.

Drug Facts — Purpose

Antiseptic

Drug Facts — Uses

Drug Facts — Warning

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

Drug Facts — Do not Use

– in children less than 2 months of age

– on open skin wounds

Drug Facts — When Using ths Product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Drug Facts — Stop Use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Drug Facts — Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Drug Facts — Directions

-place enough product on hands to cover all surfaces. Rub hands together until dry.

-Supervise children under 6 years of agen when using this product to avoid swallowing.

Drug Facts — Other Information

– Store between 15-30C (59-86F)

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

Drug Facts — Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Front/Main Label

Product Description — Hand Sanitizer

Active Ingredent — Denatured Ethanol 80%

Size in mL — this will vary depending on the package size per packagin NDC

Manufacturing location and contact information

RCD HAND SANITIZER hand sanitizer liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73977-001 Route of Administration TOPICAL 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 0.125 mL in 100 mL GLYCERIN 1.45 mL in 100 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73977-001-01 125 mL in 1 BOTTLE, PLASTIC None 2 NDC:73977-001-02 250 mL in 1 BOTTLE, PLASTIC None 3 NDC:73977-001-03 375 mL in 1 BOTTLE, PLASTIC None 4 NDC:73977-001-05 500 mL in 1 BOTTLE, PLASTIC None 5 NDC:73977-001-10 1000 mL in 1 BOTTLE, PLASTIC None 6 NDC:73977-001-19 1893 mL in 1 BOTTLE, PLASTIC None 7 NDC:73977-001-38 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 03/25/2020

Labeler — Rush Creek Distilling, LLC (013420004)

Registrant — Rush Creek Distilling, LLC (013420004)

Establishment
Name	Address	ID/FEI	Operations
Rush Creek Distilling, LLC		013420004	manufacture (73977-001)

Revised: 03/2020 Rush Creek Distilling, LLC