DERMASIL- dimethicone lotion

Dermasil by

Drug Labeling and Warnings

Dermasil by is a Otc medication manufactured, distributed, or labeled by Rise International Group LLC, Kingkey Daily Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, 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, 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

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®
Dry Skin Treatment
ORIGINAL LOTION
8 FL.OZ. (1/2 PINT, 237 ml)

INGREDIENTS AND APPEARANCE

DERMASIL 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67143-2101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67143-2101-3	237 mL in 1 BOTTLE
2	NDC: 67143-2101-2	237 mL in 1 TUBE
3	NDC: 67143-2101-5	214 mL in 1 BOTTLE

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	Business Operations
Kingkey Daily Chemical Co., Ltd.		545349263	MANUFACTURE(67143-2101)