HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by KLEAN AND SAFE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Ethyl Alcohol 75%

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

Uses

To decrease bacteria on the skin.

Recommended for repeated use.

WARNINGS

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

WHEN USING

When using this product, do not use in or near the eyes.In case of contact, rinse eyes thoroughly with

water.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help.

DOSAGE & ADMINISTRATION

Directions

Not recommended for infants.

Wet hands thoroughly with product and allow to dry without wiping.

Children under 6 years of age should be supervised when using this product.

STORAGE AND HANDLING

Other Information

Do not store above 110°F. May discolor some fabrics.

INACTIVE INGREDIENT

Inactive Ingredients

Water,Glycerin, Acrylates/C1O-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77616-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77616-002-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/18/2020

Labeler - KLEAN AND SAFE LLC (117517889)