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Product NDC Code | 10967-675 | ||||
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Drug Name | Eight hour night |
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Type | Brand | ||||
Pharm Class | Skin Barrier Activity [PE] | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | EMULSION | ||||
Application Number | M016 | ||||
Labeler Name | REVLON | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Active Ingredient Purpose Dimethicone 2.0%...................................... 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.As Needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients PETROLATUM, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, LANOLIN, ISONONYL ISONONANOATE, HYDROGENATED POLYISOBUTENE, ISOPROPYL MYRISTATE, ISOPROPYL PALMITATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, POLYBUTENE, TRIISOSTEARIN, OLEYL ERUCATE, POLYPROPYLENE, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, SYNTHETIC WAX, CYCLOPENTASILOXANE, RICINUS COMMUNIS (CASTOR) SEED OIL, GLYCERYL BEHENATE/EICOSADIOATE, HYDROGENATED LECITHIN, DIMETHICONOL, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, PARFUM/FRAGRANCE, SALICYLIC ACID, TOCOPHEROL, TOCOPHERYL ACETATE, VEGETABLE OIL/OLUS/HUILE VEGETALE, ALPHA-ISOMETHYL IONONE, BENZYL SALICYLATE, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, YELLOW 6 LAKE (CI 15985).
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.Treats symptoms of chapped or cracked skin Helps prevent and protect from drying effects of wind and cold weather
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.EIGHT HOUR NIGHT DIMETHICONE ISOPROPYL MYRISTATE SALICYLIC ACID .BETA.-CITRONELLOL, (R)- LIMONENE, (+)- GLYCERYL BEHENATE/EICOSADIOATE ISOPROPYL PALMITATE SYNTHETIC WAX (1200 MW) CYCLOMETHICONE 5 ISONONYL ISONONANOATE HYDROGENATED POLYBUTENE (1300 MW) SHEA BUTTER OLEYL ERUCATE PETROLATUM MINERAL OIL TOCOPHEROL CORN OIL ISOMETHYL-.ALPHA.-IONONE DIMETHICONE DIMETHICONE MICROCRYSTALLINE WAX LANOLIN DIMETHICONOL (100000 CST) GERANIOL FD&C YELLOW NO. 6 ALPHA-TOCOPHEROL ACETATE POLYPROPYLENE (30000 MW) HYDROGENATED SOYBEAN LECITHIN
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.carton art eight hr night
Instructions for use
Information about safe handling and use of the drug product.Uses and Directions Uses - Treats symptoms of chapped or cracked skin. - Helps prevent and protect from drying effects of wind and cold weather. Directions - Apply liberally as often as necessary
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
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 Warnings For external use only When using this product - Avoid contact with eyes - Do not apply over puncture wounds, infections or lacerations Stop using and ask a doctor if - Symptoms persist more than 7 days
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