DERMASIL- 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 pharmaceutical skincare, a powerful dry skin treatment and skin protectant. This 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 severe 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

Directions

Inactive Ingredients

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

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®
Dry Skin Treatment
ORIGINAL LOTION

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

Principal Display Panel - Bottle Label Dermasil 16oz
DERMASIL 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67143-0101
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)  
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67143-0101-1472 mL in 1 BOTTLE
2NDC:67143-0101-5429 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(67143-0101)

Revised: 1/2014
Document Id: c4e2b772-dbfe-443b-99a3-7bf1dd1b16a0
Set id: 985d0bdb-2a45-43a7-9267-6504d76de39c
Version: 7
Effective Time: 20140113
 
Rise International Group LLC