HAND SANITIZER- alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Custom Chemicial Solutions, Royal Chemical Company, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 productavoid 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 doctorif 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.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77955-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77955-003-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/06/2020

Labeler - Custom Chemicial Solutions (081096319)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(77955-003)