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| Product NDC Code | 82350-352 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Skinuva scar plus |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M020 | ||||||
| Labeler Name | MD Medical Designs, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Purpose Data on file Zinc Oxide 10% Sunscreen Dosage Form Cream
| Zinc Oxide 10% | Sunscreen |
| Dosage Form | Cream |
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 Make sure the affected area is clean and dry. Apply a thin film over the affected area twice a day, morning and night. Wait 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. See insert for detailed instructions.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water/Aqua, Dimethicone, Dimethiconol, Cyclopentasiloxane, Dimethicone Crosspolymer, Butylene Glycol, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone/PEG-10/15 Crosspolymer, Tetrahexyldecyl Ascorbate, Centella Asiatica Extract, Diphenylsiloxy Phenyl Trimethicone, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Ethylhexylglycerin, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, sh-Polypeptide-1, Tocopherol, sh-Polypeptide-6, sh-Polypeptide-5
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 Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Active ingredients Purpose Data on file Zinc Oxide 10% Sunscreen Dosage Form Cream
| Zinc Oxide 10% | Sunscreen |
| Dosage Form | Cream |
Spl product data elements
Usually a list of ingredients in a drug product.Skinuva Scar plus Zinc Oxide Zinc Oxide Zinc Oxide Water Dimethicone Cyclomethicone 5 Butylene Glycol Glycerin Diethylhexyl 2,6-Naphthalate Dimethicone/PEG-10/15 Crosspolymer Tetrahexyldecyl Ascorbate Centella Asiatica Triterpenoids Diphenylsiloxy Phenyl Trimethicone Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer Ethylhexylglycerin Sodium Chloride Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone Hyaluronate Sodium Aloe Vera Leaf BASIC FIBROBLAST GROWTH FACTOR (HUMAN) Tocopherol Phenoxyethanol Interleukin-10
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 - 30 mL Bottle Carton NDC: 82350-352-30 SKINUVA ® scar+ BROAD SPECTRUM SPF 30 Scar photoaging defense cream using highly selective growth factors with Zinc Oxide mineral sunscreen Developed and tested by physicians 30 mL / 1 fl. oz e Principal Display Panel - 30 mL Bottle Carton
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
Dist. by: MD Medical Designs, Inc. Beverly Hills, CA 90210
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 damaged/broken skin or open wounds.
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.
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 rash or irritation occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. If contact occurs, rinse eyes thoroughly with plenty of water to remove. If swallowed immediately seek medical advice and show container or label.
Storage and handling
Information about safe storage and handling of the drug product.Other information Do not use if inner seal is broken. Store at room temperature. Avoid excessive heat.
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 use on damaged/broken skin or open wounds. When using this product keep out of eyes. If contact occurs, rinse eyes thoroughly with plenty of water to remove. If swallowed immediately seek medical advice and show container or label. Stop use and ask a doctor if rash or irritation occurs. Keep out of reach of children.
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