Label: DERMASIL DRY SKIN LOTION TREATMENT LOTION - dimethicone lotion
- NDC Code(s): 17500-2101-4
- Packager: Kingkey Daily Chemical Co LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
Dermasil® Labs has developed Dermasil® OTC pharmaceuticals skincare, a powerful dry skin treatment and skin protectant.Close
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 & USAGE
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.Close
- SPL UNCLASSIFIED SECTION
• Temporarily protects and helps relieve chapped or cracked skin.
• Helps protect from the drying effects of wind and cold weather.
- 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.
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
Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml)
Tube Label Dermasil 10ozClose
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Dry Skin Treatment
10 FL.0Z (5/8 PINT. 296 ml)
- INGREDIENTS AND APPEARANCE
DERMASIL DRY SKIN LOTION TREATMENT LOTION
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17500-2101 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:17500-2101-4 296 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 - Kingkey Daily Chemical Co LTD (001181027) Establishment Name Address ID/FEI Business Operations Kingkey Daily Chemical Co LTD 001181027 MANUFACTURE