DERMASIL ADVANCED- dimethicone lotion 
Rise International Group LLC

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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Dermasil® Labs has developed Dermasil® OTC Advanced Treatment, a powerful extra-dry skin moisturizer and protectant. Enhanced with Vitamins E & B3, this nutrient-rich creamy lotion contains four systems to control and provide long-lasting relief from severe dry skin:

 
Occlusives to block moisture loss from the skin's surface
 
Humectant to bind water in the skin's outermost layers
 
Skin Lipids to enhance the skin's natural ability to retain moisture
 
EFA's an important component of the skin's moisture barrier

Indications:

Suitable for extra-dry skin, and control of symptoms such as chapping, cracking, flaking, roughness, redness, soreness, and the itching associated with dry skin.

Drug Facts

Active Ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

Warnings

  • 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

Inactive Ingredients

Water (Aqua), Petrolatum, Mineral OiL (Parraffinum Liquidum), Glycerin, Stearic Acid, Glycol Stearate, Glyceryl Stearate, PEG-40 Stearate, Cetyl Alcohol, Phenoxyethanol, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Magnesium Aluminum Silicate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Sodium Hydroxide, Acetylated Lanolin Alcohol, Carbomer, Disodium EDTA, 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, Niacinamide, Inositol.

Questions/Comments? 1-800-282-1813

Figure
Cruelty-Free. No Animal Testing.
Please Recycle This Bottle.

www.riseintlgroup.com
RISE INTERNATIONAL GROUP LLC
Lodi, NJ 07644. Made in China
©RISE INTERNATIONAL GROUP LLC

Principal Display Panel - Bottle Label Dermasil 16oz

Dermasil®
LABS

Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Advanced Treatment
CREAMY LOTION

16 FL.OZ. (1 PINT, 472 ml)

Principal Display Panel - Bottle Label Dermasil 16oz
DERMASIL ADVANCED 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67143-0100
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)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM (UNII: I38ZP9992A)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CETYL OLEATE (UNII: 78K2L26L8N)  
LANOLIN (UNII: 7EV65EAW6H)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
BORAGE OIL (UNII: F8XAG1755S)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ALMOND OIL (UNII: 66YXD4DKO9)  
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:67143-0100-1472 mL in 1 BOTTLE
2NDC:67143-0100-5429 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/15/2009
Labeler - Rise International Group LLC (011184988)
Establishment
NameAddressID/FEIBusiness Operations
Kingkey Daily Chemical Co., Ltd.545349263MANUFACTURE(67143-0100)

Revised: 1/2014
Document Id: 71c70eda-c2a8-4a59-9470-4db06c51280f
Set id: 142ec9e6-30dc-4bff-b0c0-d3864c5c1e6f
Version: 7
Effective Time: 20140113
 
Rise International Group LLC