LEADERS MEDIU PURIFYING SALT PACK- allantoin gel

Leaders Mediu Purifying Salt Pack by

Drug Labeling and Warnings

Leaders Mediu Purifying Salt Pack by is a Otc medication manufactured, distributed, or labeled by SANSUNG LIFE & SCIENCE CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.50%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Dipropylene Glycol, Butylene Glycol, Alcohol, Bentonite, Kaolin, Magnesium Aluminum Silicate, Polyvinyl Alcohol, Titanium Dioxide, Caprylic/Capric Triglyceride, Betaine, Sodium Chloride, Decylene Glycol, Ethylhexylglycerin, Hexylene Glycol, Boswellia serrata resin extract, Fragrance, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan gum, Ferric Ammonium Ferrocyanide, Isohexadecane, Polysorbate 80, Rubus coreanus fruit extract, Cnidium officinale root extract, Snail secretion filtrate, Disodium EDTA, CI 19140, CI 42090, Totarol

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician.

Use immediately after opening. Store in cool and dry place. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Directions

Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week.

Directions

Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADERS MEDIU PURIFYING SALT PACK 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69424-490
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	50 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69424-490-01	10 mL in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/01/2015

Labeler - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)

Registrant - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)

Establishment
Name	Address	ID/FEI	Business Operations
SANSUNG LIFE & SCIENCE CO., LTD.		689524929	manufacture(69424-490)