DERMASIL SENSITIVE - 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 Sensitive Skin Formula, a powerful sensitive 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 sensitive 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, Allantoin, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Acetylated Lanolin Alcohol, Carbomer, Propylparaben, 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.

Questions/Comments? 1-800-282-1813

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 8oz

Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Sensitive Skin Treatment
LOTION
8 FL.OZ (1/2 PINT, 237 ml)

DERMASIL SENSITIVE
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67143-3102
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
dimethicone (dimethicone)	dimethicone	1 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
PETROLATUM
MINERAL OIL
GLYCERIN
STEARIC ACID
GLYCOL STEARATE
GLYCERYL MONOSTEARATE
TROLAMINE
PEG-40 STEARATE
CETYL ALCOHOL
DMDM HYDANTOIN
MAGNESIUM
METHYLPARABEN
ALLANTOIN
SUNFLOWER OIL
CETYL OLEATE
LANOLIN
CARBOMER HOMOPOLYMER TYPE C
PROPYLPARABEN
EDETATE DISODIUM
LECITHIN, SOYBEAN
BORAGE OIL
CHOLESTEROL
ASCORBYL PALMITATE
ALMOND OIL
SANDALWOOD OIL
ROSA DAMASCENA FLOWER
VANILLA

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67143-3102-2	237 mL in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/15/2009

Labeler - Rise International Group LLC (011184988)

Establishment
Name	Address	ID/FEI	Operations
Kingkey Daily Chemical Co., Ltd.		545349263	MANUFACTURE

Revised: 09/2011 Rise International Group LLC