Dermasil® Labs has developed Dermasil® OTC Sensitive Skin Formula, a powerful skin treatment treatment and 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, 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, 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.

Cruelty-Free. No Animal Testing.
Please Recycle This Tube.

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RISE INTERNATIONAL GROUP LLC
Lodi, NJ 07644. Made in China
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Questions/Comments? 1-800-282-1813

Principal Display Panel - Tube Label Dermasil 10oz

DERMASIL SENSITIVE
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67143-2102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O)	dimethicone	0.01 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:67143-2102-4	296 mL in 1 TUBE
2	NDC:67143-2102-6	274 mL in 1 TUBE

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

Labeler - Rise International Group LLC (011184988)

Name	Address	ID/FEI	Business Operations
Establishment
Kingkey Daily Chemical Co., Ltd.		545349263	MANUFACTURE(67143-2102)