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

  • 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, Magnesium Aluminum Silicate, Methylparaben, 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)

Figure
DERMASIL 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67143-0101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dimethicone (dimethicone) dimethicone1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PETROLATUM 
MINERAL OIL 
GLYCERIN 
STEARIC ACID 
GLYCOL STEARATE 
GLYCERYL MONOSTEARATE 
TROLAMINE 
PEG-40 STEARATE 
CETYL ALCOHOL 
DMDM HYDANTOIN 
MAGNESIUM 
METHYLPARABEN 
SUNFLOWER OIL 
CETYL OLEATE 
LANOLIN 
CARBOMER HOMOPOLYMER TYPE C 
PROPYLPARABEN 
EDETATE DISODIUM 
GERANIUM MACULATUM ROOT 
LECITHIN, SOYBEAN 
BORAGE OIL 
CHOLESTEROL 
ASCORBYL PALMITATE 
ALMOND OIL 
SANDALWOOD OIL 
ROSA DAMASCENA FLOWER 
VANILLA 
Packaging
#Item CodePackage Description
1NDC:67143-0101-1472 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

Revised: 12/2011
 
Rise International Group LLC