70738-002_Deactivation

Drug Labeling and Warnings

Drug Details [pdf]

LAGOM CELLUS WHITE MOISTURE CREAM- dimethicone cream 
SKINMED International 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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70738-002_Deactivation

DIMETHICONE 1.50%

Skin Protectant

Temporarily protects chapped or cracked skin

Prevent and protect from the drying effects of wind and cold weather

After facial wash, apply a generous amount on face in the final stage of basic care. Tap with fingertips to absorb along the skin texture

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Glycerin,Cetyl Ethylhexanoate,Propanediol,Niacinamide,Cyclopentasiloxane,Caprylic/Capric Triglyceride,Polysorbate 60,Dimethicone,Glyceryl Stearate,Betaine,Cetearyl Alcohol,1,2-Hexanediol,Butyrospermum Parkii (Shea) Butter,Sorbitan Sesquioleate,Dimethicone/Vinyl Dimethicone Crosspolymer,Palmitic Acid,Cyclohexasiloxane,Hydroxyacetophenone,Stearic Acid,Polyacrylate-13,Tocopheryl Acetate,Polyisobutene,Yeast Amino Acids,Urea,Trehalose,Inositol,Taurine,Polysorbate 20,Citrus Aurantium Dulcis (Orange) Oil,Sorbitan Isostearate,Disodium EDTA,Phenoxyethanol,Lavandula Angustifolia (Lavender) Oil,Potassium sorbate,Geranium Maculatum Oil,Citrus Aurantium Bergamia (Bergamot) Fruit Oil,Santalum Album (Sandalwood) Oil,Rose Flower Oil,Chamomilla Recutita (Matricaria) Flower Oil,Styrax Benzoin Gum,Commiphora Myrrha Oil,Citric Acid,Alchemilla Vulgaris Extract,Primula Veris Extract,Veronica Officinalis Extract,Achillea Millefolium Extract,Mentha Piperita (Peppermint) Leaf Extract,Melissa Officinalis Leaf Extract,Malva Sylvestris (Mallow) Extract

LAGOM CELLUS WHITE MOISTURE CREAM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70738-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.75 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
PROPANEDIOL (UNII: 5965N8W85T)
NIACINAMIDE (UNII: 25X51I8RD4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BETAINE (UNII: 3SCV180C9W)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SHEA BUTTER (UNII: K49155WL9Y)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PALMITIC ACID (UNII: 2V16EO95H1)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
UREA (UNII: 8W8T17847W)
TREHALOSE (UNII: B8WCK70T7I)
INOSITOL (UNII: 4L6452S749)
TAURINE (UNII: 1EQV5MLY3D)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ORANGE OIL (UNII: AKN3KSD11B)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)
BERGAMOT OIL (UNII: 39W1PKE3JI)
SANDALWOOD OIL (UNII: X7X01WMQ5F)
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
MYRRH OIL (UNII: H74221J5J4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)
PRIMULA VERIS (UNII: W6LFQ57E4M)
VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70738-002-02	1 in 1 PACKAGE	12/06/2017	10/24/2019
1	NDC: 70738-002-01	50 mL in 1 CONTAINER; 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	12/06/2017	10/24/2019

Labeler - SKINMED International Co., Ltd. (689846920)

Registrant - SKINMED International Co., Ltd. (689846920)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(70738-002)

Revised: 10/2019

Document Id: 95b08287-64a6-ad92-e053-2995a90a1280

34390-5

Set id: f6637edd-fd15-4c7a-863d-5b4989e67c7d

Version: 3

Effective Time: 20191024