Active Ingredient
Dimethicone 5%
Procure Dimethicone 5% Cream
FDA Label NDC 55681-024
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 Dimethicone 5% (NDC 55681-024). 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, keep out of reach of children, directions, 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
- temporaily protects and helps relieve chafed, chapped or cracked skin
- helps protect from the drying effects of whine and cold weather
- helps treat and prevent diaper rash
- protects minor skin irritation associated with diaper rash and helps seal out wetness
Warnings
Warnings
For external use only
When Using This Product
When using this product do not get into 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
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
Directions
As a skin protectant apply as needed
As a diaper cream
- change wet and soiled diaper promptly, cleanse the diaper area and allow to dry
- apply cream liberally as often as necessary with each diaper change, expecially at bedtime or anytime when exposure to wet diaper may be prolonged
Inactive Ingredients
Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Pehenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, Edetate Disodium, Orange Oil Cold Pressed, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, .Alpha.-Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin
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