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Product NDC Code | 84697-001 | ||||
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Drug Name | Zeus |
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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 | M020 | ||||
Labeler Name | NEWPORT APOTHECARY, INC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose ZINC OXIDE 22.3% 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 APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS. 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 BROAD SPECTRUM SPF 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 SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES CHILDREN UNDER 6 MONTHS : ASK A DOCTOR
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients WATER, COCO-CAPYLATE/CAPRATE (COCOYL CAPRYLOCAPRATE), ISOAMYL LAURATE, BUTYL SALICYLATE, GLYCERIN, PROPANEDIOL, BUTYROSPERMUM PARKII (SHEA BUTTER), SIMMONDSIA CHINENSIS (JOJOBA OIL),POLYGLYCERYL-6 STEARATE, TRIDECYL SALICYLATE, POLYGLYCERYL-6 BEHENATE, ALOE BARBADENSIS LEAF EXTRACT (ALOE VERA LEAF), CAMELLIA SINENSIS (GREEN TEA LEAF), SPHINGOMONAS FERMENT EXTRACT, PONGOMIA PINNATA SEED, Silica, XANTHAN GUM, CETYL ALCOHOL, LECITHIN, SCLEROTIUM GUM (BETASIZOFIRAN), POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, PULLULAN, 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 HELPS PREVENT SUNBURN IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS ), DECREASES THE RISK OF SKIN CANCER AND EARLY AGING CAUSED BY THE SUN
Spl product data elements
Usually a list of ingredients in a drug product.ZEUS ZINC OXIDE WATER COCOYL CAPRYLOCAPRATE ISOAMYL LAURATE BUTYL SALICYLATE GLYCERIN PROPANEDIOL JOJOBA OIL SHEA BUTTER POLYGLYCERYL-6 STEARATE TRIDECYL SALICYLATE POLYGLYCERYL-6 BEHENATE ALOE VERA LEAF GREEN TEA LEAF PONGAMIA PINNATA SEED XANTHAN GUM CETYL ALCOHOL SILICON DIOXIDE SOYBEAN LECITHIN BETASIZOFIRAN POLYHYDROXYSTEARIC ACID STEARATE PULLULAN PHENOXYETHANOL ETHYLHEXYLGLYCERIN TRIETHOXYCAPRYLYLSILANE ZINC OXIDE ZINC CATION
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.Product label image description image description
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.Other information PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
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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 doctor if rash or irritation develops and lasts. Keep out of reach of children If product is swallowed, get medical help of 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