LUTHIONE HAND- alcohol spray

LUTHIONE HAND by

Drug Labeling and Warnings

LUTHIONE HAND 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, Glycerin, Polysorbate 20, Tocopheryl Acetate, Sodium Hyaluronate

PURPOSE

Antiseptic

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

For the external use only

WARNINGS

Warnings

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

Do not use

■ in children less than 2 months of age

■ on open skin wounds

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

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

■ Supervise children under 6 years of age when using this product to avoid swallowing..

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUTHIONE HAND 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74777-033
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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONIC ACID (UNII: S270N0TRQY)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74777-033-02	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - MYUNG COSMETIC (688222692)

Registrant - MYUNG COSMETIC (688222692)

Establishment
Name	Address	ID/FEI	Business Operations
MYUNG COSMETIC		688222692	manufacture(74777-033)