OTC Medication Information: HAND SANITIZER

HAND SANITIZER- alcohol gel
Custom Chemicial Solutions

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 ingredients (v/v)

Ethyl Alcohol 70%

Purpose

Antimicrobial

Uses:

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

Warnings

For external use only: hands

Flammable. Keep away from fire or flame.

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Avoid contact with broken skin.

Do not ingest or inhale.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions:

Pump enough product into palm of hand to thoroughly cover all surfaces of both hands.

Rub hands together briskly until dry.

For children under 6, use only under adult supervision

Other Information:

Store below 110 F (43 C).

May discolor some fabrics.

May be harmful to wood finishes and plastics.

Inactive ingredients:

Water (Eau), Triisopropanolamine, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Fragrance (Parfum), Isopropyl Myristate, Tocopheryl Acetate, Denatonium Benzoate.

HAND SANITIZER

GEL

Contains 70% Alcohol

GENTLE ON HANDS

500 MLS (16.9 US fl. oz)

Manfactured for:

Custom Chemical Solutions, LLC

167 Commerce Drive

Loveland, OH 45140

HAND SANITIZER alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77955-003 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 GLYCERIN CARBOMER INTERPOLYMER TYPE A (55000 CPS) .ALPHA.-TOCOPHEROL ACETATE WATER ISOPROPYL MYRISTATE TRIISOPROPANOLAMINE PROPYLENE GLYCOL DENATONIUM BENZOATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:77955-003-03 500 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/06/2020

Labeler — Custom Chemicial Solutions (081096319)

Establishment
Name	Address	ID/FEI	Operations
Royal Chemical Company, Ltd.		798846874	manufacture (77955-003)

Revised: 07/2021 Custom Chemicial Solutions