Active Ingredient
Active Ingredient Purpose
Dimethicone 2.0%...................................... Skin Protectant
Eight Hour Night Emulsion
FDA Label NDC 10967-675
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Revlon for the product Eight Hour Night (NDC 10967-675). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, uses and directions, warnings, carton art, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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).
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
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
* Please review the disclaimer below.
