DERMASIL ADVANCED- dimethicone lotion 
Kingkey MBC Life Technology Group 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

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)image description

NDC: 73928-101-01

DERMASIL ADVANCED 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73928-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73928-101-01236 mL in 1 TUBE; Type 0: Not a Combination Product07/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/17/2023
Labeler - Kingkey MBC Life Technology Group Co., Ltd. (545349263)
Establishment
NameAddressID/FEIBusiness Operations
Kingkey MBC Life Technology Group Co., Ltd.545349263manufacture(73928-101)

Revised: 7/2023
Document Id: 174e201c-8f17-4a04-8a3e-22133282ffc9
Set id: da09e418-e9b1-42d5-8685-18cd601cc8f6
Version: 1
Effective Time: 20230717
 
Kingkey MBC Life Technology Group Co., Ltd.