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 pharmaceuticals 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

  • 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 as needed

Inactive Ingredients

Water (Aqua), Petrolatum, Mineral Oil (Parraffinum Liquidum),Glycerin, Stearic Acid, Glycol Stearate, Glyceryl Stearate, Triethanolamine, PEG-40 Stearate, Cetyl Alcohol, DMDM Hydantoin, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Magnesium Aluminum Silicate, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Acetylated Lanolin Alcohol, Carbomer, 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

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

Questions/Comments? 1-800-282-1813

Principal Display Panel - Tube Label Dermasil 10oz

25% MORE
Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
10 FL.OZ (5/8 PINT, 296 ml)

Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml)
DERMASIL 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67143-2101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PETROLATUM 
MINERAL OIL 
GLYCERIN 
STEARIC ACID 
GLYCOL STEARATE 
GLYCERYL MONOSTEARATE 
CETYL ALCOHOL 
MAGNESIUM ALUMINUM SILICATE 
IODOPROPYNYL BUTYLCARBAMATE 
SUNFLOWER OIL 
CETYLPYRIDINIUM ACETATE 
CARBOMER HOMOPOLYMER TYPE C 
METHYLISOTHIAZOLINONE 
EDETATE DISODIUM 
LECITHIN, SOYBEAN 
BORAGE 
CHOLESTEROL 
ASCORBYL PALMITATE 
ALMOND 
VANILLA 
GERANIUM MACULATUM ROOT 
Packaging
#Item CodePackage Description
1NDC:67143-2101-4296 mL in 1 TUBE
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 LTD545349263MANUFACTURE(67143-2101)

Revised: 09/2011
Document Id: cc8f668c-bba0-4d7e-b8eb-239103ab956c
Set id: 51eb9d32-52b5-4cea-aa6e-c1770437c4ac
Version: 2
Effective Time: 20110914
 
Rise International Group LLC