FDA Label for Renew Dimethicone Skin Protectant

View Indications, Usage & Precautions

Renew Dimethicone Skin Protectant Product Label

The following document was submitted to the FDA by the labeler of this product Dermarite Industries Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient:



Dimethicone 5%


Purpose:



Skin Protectant


Uses:



  • Forms a moisture barrier that prevents and helps treat effects associated with diaper rash from wetness, urine, or stool.
  • Temporarily protects and helps relieve chapped or cracked skin.

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.
  • Do not use on deep or punctured wounds.
  • Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.


Directions:



Clean skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply as necessary. If applying to perineal area, apply after each incontinent episode or diaper change to promote comfort and long lasting protection.


Other Information:



Store at room temperature (59 o- 86 oF)


Inactive Ingredients:



Aloe Barbadensis Leaf Juice, Aluminum Stearate, Cera Alba, Cholecalciferol, Chloroxylenol, Corn Oil, Imidiazolidinyl Urea, Dicocoyl Pentaerythrityl Distearyl Citrate, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water.


Questions?



Call 1-800-37-6296


Renew Skin Protectant Package Label Principal Display Panel




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