FDA Label for Dermasarra

View Indications, Usage & Precautions

Dermasarra 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



Camphor 0.5%


Purpose



External Analgesic


Uses:



Temporary relief of itching associiated with minor skin irritations due to:

  • dry skin
  • insect bites
  • detergent
  • sunburn

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, symptoms last for more than 7 days, symptoms clear up and occur again within a few days
  • Do not use on deep puncture wounds, animal bites, or serious burns.

Warnings



  • Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away

Directions:



Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times dialy,

Children under 2 years of age: Consult a doctor


Other Infomation:



Store at room temperature (59°-86°F)

You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047


Inactive Ingredients:



water, Cetearyl Alcohol, PEG-40 Castor Oil, Sodium Cetearyl Sulfate, Stearic Acid, Glycol Stearate, Mineral Oil, Dimethicone, PEG-4 Dilaurate, Propylene Glycol, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Titanium Dioxide, menthol, Carbomer, Petrolatum, Disodium EDTA


* Please review the disclaimer below.