LUTHIONE FRESH HAND GEL- alcohol gel

LUTHIONE FRESH HAND Gel by

Drug Labeling and Warnings

LUTHIONE FRESH HAND Gel by is a Otc medication manufactured, distributed, or labeled by MYUNG COSMETIC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol

INACTIVE INGREDIENT

Water, Polysorbate 20, Aminomethyl Propanol, Tocopheryl Acetate, Sodium Hyaluronate, Glycerin, Carbomer

PURPOSE

Antiseptic

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

For the external use only

WARNINGS

Do not use on the following body parts.
Around the eyes and ears, in the oral cavity, a wide range of body parts and damaged skin (may have irritating effects)
If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.

Symptoms of skin irritation

Other precautions

For external use only
Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
Be careful not to inhale vapor when using it extensively or for a long time. (If you drink ethanol vapor in large quantities or repeatedly, irritation to the mucous membrane, headache, etc. may occur).
When repeated use on the same site, be careful as the skin may become rough due to degreasing.
When used in sealed bandages, cast bandages, packs, etc., irritation symptoms may appear.
Do not use for any other purpose.

DOSAGE & ADMINISTRATION

Put enough amount on your hand and briskly rub hands together until it dries.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUTHIONE FRESH HAND GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74777-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 g  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74777-032-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/20/2020

Labeler - MYUNG COSMETIC (688222692)

Registrant - MYUNG COSMETIC (688222692)

Establishment
Name	Address	ID/FEI	Business Operations
MYUNG COSMETIC		688222692	manufacture(74777-032)