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Dermasil advanced - Medication Information

Product NDC Code 76184-0100
Drug Name

Dermasil advanced

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone .01 g/ml
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 199680,
880878
Application Number M016
Labeler Name Fantasia Beauty LLC
Packages
Package NDC Code Description
76184-0100-2 236 ml in 1 tube (76184-0100-2)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Dimethicone 1%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Apply to Hands and Body every day.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: WATER (AQUA), GLYCERIN, PETROLATUM, MINERAL OIL (PARAFFINUM LIQUIDUM), STEARIC ACID, GLYCOL STEARATE, GLYCERYL STEARATE, PEG-40 STEARATE, CETYL ALCOHOL, CETYL ACETATE, SODIUM HYDROXIDE, PHENOXYETHANOL, CARBOMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DISODIUM EDTA, ACETYLATED LANOLIN ALCOHOL, METHYLISOTHIAZOLINONE, IODOPROPYNYL BUTYLCARBAMATE, FRAGRANCE, MAGNESIUM ALUMINUM SILICATE, 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, NIACINAMIDE, INOSITOL.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.

Purpose

Information about the drug product’s indications for use.
Purpose Skin protectant

Spl product data elements

Usually a list of ingredients in a drug product.
DERMASIL ADVANCED DIMETHICONE DIMETHICONE DIMETHICONE WATER GLYCERIN PETROLATUM MINERAL OIL STEARIC ACID GLYCOL STEARATE GLYCERYL MONOSTEARATE PEG-40 STEARATE CETYL ALCOHOL CETYL OLEATE SODIUM HYDROXIDE PHENOXYETHANOL CARBOMER HOMOPOLYMER TYPE C SUNFLOWER OIL EDETATE DISODIUM ACETYLATED LANOLIN ALCOHOLS METHYLISOTHIAZOLINONE IODOPROPYNYL BUTYLCARBAMATE MAGNESIUM ALUMINUM SILICATE LECITHIN, SOYBEAN BORAGE OIL CHOLESTEROL ASCORBYL PALMITATE ALMOND OIL ETHYLENE BRASSYLATE SANDALWOOD OIL ROSA DAMASCENA FLOWER VANILLA NIACINAMIDE INOSITOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel - Dermasil Advanced 8 Tube Label Dermasil ® LABS Pharmaceutical Research Controls Even Sever Dry Skin Skin Lipid & EFA Treatment Hypo-Allergenic Dermasil ® Advanced Treatment CREAMY LOTION 8 FL OZ (236 ml) Principal Display Panel - Dermasil Advanced 8 Tube Label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API