Active Ingredients
Dimethicone 1% w/w
Zinc Oxide 12% w/w
Procure Moisture Barrier Cream
FDA Label NDC 55681-025
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 Moisture Barrier (NDC 55681-025). 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 ingredients, 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
- 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 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
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
- 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, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive Ingredients
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Aluminum Stearate, Beeswax, Cholecalciferol, Chloroxylenol, Corn Oil, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Lanolin, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sorbitan Sesquioleate, Tocopherol Acetate, Vitamin A Palmitate, Water
* Please review the disclaimer below.
