The following Structured Product Label (SPL) was submitted to the FDA by Elizabeth Arden, Inc for the product Eight Hour Cream Skin Protectant (NDC 67938-0105). 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 description, indications and usage, warnings, otc - active ingredient, inactive ingredient, dosage & administration, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(On Box) Uses: Treats symptoms of: chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions, cracked lips.
(On Tube) Soothes minor skin irritations. Also for symptoms of chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions or cracked lips.
To Use: Apply liberally as often as necessary.
(On Box) 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.
(On Tube) Warning: For external use only. Avoid contact with eyes. Discontinue use if symptoms persist more than 7 days and consult a physician. Not to be applied over puncture wounds, infections, or lacerations.
Active Ingredient: Petrolatum 56.8%.
Inactive Ingredients: Lanolin, Mineral Oil, Tocopherol, BHT, Salicylic Acid, Rincinus Communis (Castor) Seed Oil, Vegetable Oil, Zea Mays (Corn) Oil, Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Propylparaben, Iron Oxides.
Apply liberally.
Keep out of reach of children.
Skin protectant.
Avoid contact with eyes.
* Please review the disclaimer below.
