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| Product NDC Code | 62742-4145 | ||||
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| Drug Name | Pyratine xr creme with sunscreen broad spectrum spf30 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Allure Labs 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 Ingredient: Zinc oxide - 18.6%
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 generously 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Propylene Glycol, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Hexylene glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan gum, Furfuryl Tetrahydropyranyladinine, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract and Micrococcus Lysate.
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: Help prevent sunburn. Higher SPF gives more sunburn protection. Provide high protection against sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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.Pyratine XR Creme With Sunscreen Broad Spectrum SPF30 Zinc Oxide ZINC OXIDE ZINC CATION WATER DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) BUTYLENE GLYCOL GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL STEARATE SE PEG-100 STEARATE POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) CYCLOMETHICONE 6 SORBITAN MONOSTEARATE POLYACRYLAMIDE (10000 MW) C13-14 ISOPARAFFIN LAURETH-7 PHENOXYETHANOL CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL IMPERATA CYLINDRICA ROOT POLYETHYLENE GLYCOL 400 CARBOMER 1342 CETYL ALCOHOL LECITHIN, SOYBEAN TOCOPHEROL ASCORBYL PALMITATE ASCORBIC ACID CITRIC ACID MONOHYDRATE XANTHAN GUM POLYESTER-7 NEOPENTYL GLYCOL DIHEPTANOATE .ALPHA.-TOCOPHEROL LINOLEATE, D- TEPRENONE DATE POLYGONUM AVICULARE TOP SODIUM LACTATE EDETATE DISODIUM ANHYDROUS GLYCYRRHIZINATE DIPOTASSIUM ARABIDOPSIS THALIANA MICROCOCCUS LUTEUS TRIETHOXYCAPRYLYLSILANE
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.Developed, Distributed and Marketed by: Pyratine LLC 2950 Main Street Morro Bay, CA 93442 1-888-467-9728 www.pyratine.com Image Pyratine XR
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 Cpntrol center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.protect this product from excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call toll free 1-888-467-9728
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 developes and lasts.
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.
Storage and handling
Information about safe storage and handling of the drug product.Store at controlled room temperature 59 F - 89 F (15 C - 30 C).
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.
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