LEADERS MEDIU ELASTICITY GOLD PACK- dimethicone gel
SANSUNG LIFE & SCIENCE CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active Ingredient: Dimethicone 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Cetyl Ethylhexanoate, Butylene Glycol, Glyceryl Stearate, Polysorbate 60, Mica, PEG-100 Stearate, Titanium Dioxide, Iron Oxides, Gold, Zanthoxylum Piperitum fruit extract, Pulsatilla koreana extract, Usnea barbata (lichen) extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trehalose, Betaine, Carbomer, Tromethamine, Fragrance, PVP, Sodium Citrate, Disodium EDTA

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cello pack

LEADERS MEDIU ELASTICITY GOLD PACK
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69424-470
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.2 g in 10 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69424-470-01	10 mL in 1 CELLO PACK; Type 0: Not a Combination Product

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

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

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

Name	Address	ID/FEI	Business Operations
Establishment
SANSUNG LIFE & SCIENCE CO., LTD.		689524929	manufacture(69424-470)