Label: DERMASIL- dimethicone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 67143-2101-4, 67143-2101-6 - Packager: Rise International Group LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 13, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
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:
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SPL UNCLASSIFIED SECTION
Drug Facts
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.
Inactive Ingredients
Water (Aqua), Petrolatum, Mineral Oil (Parraffinum Liquidum),Glycerin, Stearic Acid, Glycol Stearate, Glyceryl Stearate, PEG-40 Stearate, Cetyl Alcohol, Phenoxyethanol, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Magnesium Aluminum Silicate, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Sodium Hydroxide, 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
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
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INGREDIENTS AND APPEARANCE
DERMASIL
dimethicone lotionProduct 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) CETYL ALCOHOL (UNII: 936JST6JCN) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) SUNFLOWER OIL (UNII: 3W1JG795YI) CETYLPYRIDINIUM ACETATE (UNII: 6W29RZ7YU2) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) EDETATE DISODIUM (UNII: 7FLD91C86K) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) BORAGE (UNII: PB618V0K2W) CHOLESTEROL (UNII: 97C5T2UQ7J) ASCORBYL PALMITATE (UNII: QN83US2B0N) ALMOND (UNII: 3Z252A2K9G) VANILLA (UNII: Q74T35078H) GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67143-2101-4 296 mL in 1 TUBE 2 NDC:67143-2101-6 274 mL in 1 TUBE 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)