LEADERS MEDIU SOOTHING ALOE PACK- allantoin gel

Leaders Mediu Soothing Aloe Pack by

Drug Labeling and Warnings

Leaders Mediu Soothing Aloe 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, 1,2-Hexanediol, Butylene Glycol, Arginine, Carbomer, PEG-60 Hydrogenated Castor Oil , Aloe barbadensis Leaf Juice Powder, Sodium Polyacrylate, Portulaca Oleracea extract , Cucumis Sativus (Cucumber) Fruit extract, Fragrance, Buteth-3, Glyceryl Acrylate/Acrylic Acid Copolymer, Maltodextrin, PVM/MA Copolymer, Disodium EDTA, Sodium Benzotriazolyl Butylphenol Sulfonate, Tributyl Citrate, CI 19140, CI 42090, Sodium Hyaluronate

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 SOOTHING ALOE PACK 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69424-530
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: 69424-530-01	10 mL in 1 CELLO PACK; 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(69424-530)