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Product NDC Code | 71574-500 | ||||
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Drug Name | Scarzen |
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Type | Brand | ||||
Pharm Class | Skin Barrier Activity [PE] | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 1602161 | ||||
Application Number | M016 | ||||
Labeler Name | Village Pharma LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS: Dimethicone 5.00% Skin Protectant
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 (Adults and Children Over 12 Years): Cleanse the affected area and allow to dry. Apply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Aqua (Deionized Water), Aloe Barbadensis (Aloe Vera Gel) Juice, Glyceryl Stearate, PEG-100 Stearate, Carthamus Tinctorius (Sunflower) Oil, Stearic Acid, Cetyl Alcohol, Butylene Glycol, Glycerin, Sodium Ascorbyl Phosphate (Vitamin C), Tocopheryl Acetate (Vitamin E), Hyaluronic Acid, Zingiber Officinale (Ginger) Extract, Pyridoxine HCL (Vitamin B6), Pantothenic Acid (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Disodium EDTA, Silica, Triethanolamine, Parfum (Fragrance), Phenoxyethanol, Ethylhexylglycerin.
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
Purpose
Information about the drug product’s indications for use.Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Scarzen DIMETHICONE WATER ALOE VERA LEAF GLYCERYL MONOSTEARATE PEG-100 STEARATE STEARIC ACID CETYL ALCOHOL BUTYLENE GLYCOL GLYCERIN SODIUM ASCORBYL PHOSPHATE HYALURONIC ACID GINGER PYRIDOXINE HYDROCHLORIDE PANTOTHENIC ACID SAFFLOWER EDETATE DISODIUM ANHYDROUS SILICON DIOXIDE TROLAMINE PHENOXYETHANOL ETHYLHEXYLGLYCERIN DIMETHICONE DIMETHICONE
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.Package Labeling: Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS:
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on deep or puncture wounds, animal bites or serious burns.
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 or 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. Avoid contact with eyes. Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days. Do not use on deep or puncture wounds, animal bites or serious burns. 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