DERMASIL ADVANCED by Fantasia Accessories LTD / Kingkey MBC Life Technology Group Co., Ltd.

DERMASIL ADVANCED by

Drug Labeling and Warnings

DERMASIL ADVANCED by is a Otc medication manufactured, distributed, or labeled by Fantasia Accessories LTD, Kingkey MBC Life Technology Group Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DERMASIL ADVANCED- dimethicone lotion 
Fantasia Accessories LTD

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ACTIVE INGREDIENT

Dimethicone 1%

PURPOSE

Skin protectant

Use

Temporarily protects and helps relieve chapped or cracked skin.
Helps protect from the drying effects of wind and cold weather.

Warnings

For external use only.
Do not get into eyes.
Stop use and ask a doctor if: Condition worsens, Symptoms last more than 7 days or clear up and occur again within a few days.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply to Hands and Body every day.

INACTIVE INGREDIENTS:

WATER (AQUA), GLYCERIN, PETROLATUM, MINERAL OIL (PARAFFINUM LIQUIDUM), STEARIC ACID, GLYCOL STEARATE, GLYCERYL STEARATE, PEG-40 STEARATE, CETYL ALCOHOL, CETYL ACETATE, SODIUM HYDROXIDE, PHENOXYETHANOL, CARBOMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DISODIUM EDTA, ACETYLATED LANOLIN ALCOHOL, GERANIUM MACULATUM OIL, METHYLISOTHIAZOLINONE, IODOPROPYNYL BUTYLCARBAMATE, MAGNESIUM ALUMINUM SILICATE, LECITHIN , BORAGO OFFICINALIS SEED OIL, CHOLESTEROL, ASCORBYL PALMITATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, ETHYLENE BRASSYLATE, SANTALUM ALBUM (SANDALWOOD) OIL, ROSA DAMASCENA EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT.

Package Label - Principal Display Panel

Dermasil®

LABS

Pharmaceutical Research

Controls Even Sever Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Advanced Treatment

CREAMY LOTION

8 FL OZ (236 ml)

NDC: 76184-0111-1

DERMASIL ADVANCED 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76184-0111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCOL STEARATE (UNII: 0324G66D0E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL OLEATE (UNII: 78K2L26L8N)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BORAGE OIL (UNII: F8XAG1755S)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALMOND OIL (UNII: 66YXD4DKO9)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
SANDALWOOD OIL (UNII: X7X01WMQ5F)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
VANILLA (UNII: Q74T35078H)
NIACINAMIDE (UNII: 25X51I8RD4)
INOSITOL (UNII: 4L6452S749)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76184-0111-1	236 mL in 1 TUBE; Type 0: Not a Combination Product	07/17/2023	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/17/2023	12/31/2023

Labeler - Fantasia Accessories LTD (037273190)

Establishment
Name	Address	ID/FEI	Business Operations
Kingkey MBC Life Technology Group Co., Ltd.		545349263	manufacture(76184-0111)

Revised: 10/2023

Document Id: 0e1b97d8-79b3-40f8-a262-64b3bfd33fac

34390-5

Set id: c90f0848-4873-4909-9aa3-ad8efe8d2268

Version: 2

Effective Time: 20231009