Renew Skin Repair
FDA Label NDC 61924-405

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermarite Industries Llc for the product Renew Skin Repair (NDC 61924-405). 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:, purpose:, uses:, warnings:, directions:, other information:, inactive infredients:, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

Dimethicone 1.5%

Purpose:

Skin Protectant

Uses:

Temporarily protects and helps relieve chapped or cracked skin. Benificial for face, hands, body, and legs.

Warnings:

  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask a doctor if condition worsens or does not improve within 7 days and if symptoms clear up and occur again within a few days.
  • Do not use on deep or punctured wounds, animal bites, or serius burns.
    • Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.

Directions:

Apply cream liberally as needed.

Other Information:

  • Store at room temperature (59 o- 86 oF)
  • You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Infredients:

Water, Olea Europaea(Olive) Oil, Zea Mays (Corn) Oil, Canola Oil, Stearic Acid, glyceryl Stearate, PEG-100 Stearate, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Juice, Glycerin, Butylparaben, Ethylparaben, Isobutylparaben, methylparaben, Phenoxyethanol, propylparaben, Citrus Aurantium Dulcis (orange) Peel Oil, Anthemis Nobilis Flower Oil, Lavandula Officinalis (lavender) Oil, Fragrance, Cetearyl Alcohol, Carbomer, Ascorbyl Palmitate, Disodium EDTA, Tocopheryl Acetate, Niacinamide, Retinyl Palmitate, Cholecalciferol, Pyridoxine HCL

Questions?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

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