Active Ingredient
Dimethicone 1.5%
Procure Skin Repair Cream
FDA Label NDC 55681-033
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Procure Skin Repair Cream (NDC 55681-033). 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, when using this product, stop use and ask a doctor if, do not use on, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
Uses
- Temporarily protects and helps relieve chafed, chapped or cracked skin
- Helps protect from the drying effects of wind and cold weather
Warnings
Warnings
For external use only
When Using This Product
When using this product do not use near or get into the eyes.
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
- Condition worsens
- Symptoms last more than 7 days or clear up and occur again within a few days
Do Not Use On
Do not use on deep or puncture wounds, animal bites, serious burns
Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.
Directions
Apply as needed
Inactive Ingredients
Water, Propylene Glycol, Cetearyl Alcohol, Glycerin, Glyceryl Monostearate, Stearic Acid, PEG-100 Stearate, Carbomer, Olive Oil, Corn Oil, Canola Oil, Niacinamide, .Alpha.-Tocopherol Acetate, Vitamin A Palmitate, Cholecalciferol, Edetate Disodium, Aloe Vera Extract, Citrus Medica Limonum (Lemon) Peel Oil, Orange Oil, Cold Pressed, Lavender Oil, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol, Pyridoxine HCl, Fragrance, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6
* Please review the disclaimer below.
