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| Product NDC Code | 78317-055 | ||||
|---|---|---|---|---|---|
| Drug Name | Farmasi cc cream- medium 03 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Titanium Dioxide 4.0% Purpose: Sunscreen
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: For Sunscreen Use Apply 15 minutes before sun exposure. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water/Aqua, Cyclopentasiloxane, Phenyl Trimethicone, Peg-10 Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Disteardimonium Hectorite, Trimethylsiloxysilicate, Glycerin, Phenoxyethanol, Pancratium Maritimum Extract, Sodium Chloride, Aluminum Starch Octenylsuccinate, Silica, Jojoba Esters, Mica, Dimethicone Crosspolymer, Tocopheryl Acetate, Triethoxycaprylylsilane, Ethylhexylglycerin, Tocopherol, Fragrance.(+/- May Contain: Titanium Dioxide/CI77891, Iron Oxides/CI 77491,CI 77492, CI7749.)
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.Use: Helps prevent sunburn.
Purpose
Information about the drug product’s indications for use.Purpose: Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Farmasi CC Cream- MEDIUM 03 TITANIUM DIOXIDE WATER CYCLOMETHICONE 5 PHENYL TRIMETHICONE BUTYLENE GLYCOL BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE DIMETHICONE NIACINAMIDE DISTEARDIMONIUM HECTORITE GLYCERIN PHENOXYETHANOL SODIUM CHLORIDE ALUMINUM STARCH OCTENYLSUCCINATE SILICON DIOXIDE MICA .ALPHA.-TOCOPHEROL ACETATE TRIETHOXYCAPRYLYLSILANE ETHYLHEXYLGLYCERIN TOCOPHEROL FERRIC OXIDE RED FERRIC OXIDE YELLOW TITANIUM DIOXIDE TITANIUM DIOXIDE
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: Label04
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:
Other Information: Protect the product in this container from excessive heat and direct sun.
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 or broken skin.
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Shake well before use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? [email protected] (833) 432-7627 Monday - Friday (9 a.m - ) p.m. EST)
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 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. Rinse with water to remove.
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 or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Shake well before use.
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