Your browser does not support JavaScript! DERMASIL (DIMETHICONE) LOTION [KINGKEY DAILY CHEMICAL CO LTD]
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DERMASIL (dimethicone) lotion
[Kingkey Daily Chemical Co LTD]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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: 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

Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml)

Tube Label Dermasil 10oz
25% MORE
Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
10 FL.0Z (5/8 PINT. 296 ml)

Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml)
DERMASIL   DRY SKIN LOTION TREATMENT LOTION
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:17500-2101
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 
CETYL ALCOHOL 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
HELIANTHUS ANNUUS 
CETYLPYRIDINIUM ACETATE 
CARBOMER HOMOPOLYMER TYPE C 
PROPYLPARABEN 
EDETATE DISODIUM 
LECITHIN, SOYBEAN 
BORAGE 
CHOLESTEROL 
ASCORBYL PALMITATE 
ALMOND 
VANILLA 
GERANIUM EXTRACT 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17500-2101-4296 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/15/2009
Labeler - Kingkey Daily Chemical Co LTD (001181027)
Establishment
NameAddressID/FEIBusiness Operations
Kingkey Daily Chemical Co LTD001181027MANUFACTURE

Revised: 8/2009
 
Kingkey Daily Chemical Co LTD

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