FDA Label for Dermeleve

View Indications, Usage & Precautions

Dermeleve Product Label

The following document was submitted to the FDA by the labeler of this product Advanced Derm Solutions 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



Pramoxine Hydrochloride (1%)


Purpose



External analgesic


Uses



For temporary relief of pain and itching associated with skin irritations, minor burns, sunburn, and rashes due to poison ivy, poison oak, or poison sumac


Warnings



  • For external use only.
  • Avoidcontact with eyes. 
  • Do not apply to open wounds. 
  • STOP USE and ask a doctor if condition worsens or symptoms persist for more than seven days. 
  • Keep out of reach of children.

Directions



Adults and children two years of age and older, apply to affected area as needed or as directed by a doctor.

Consult a doctor for children under the age of two.


Inactive Ingredients



Ascorbyl Tetraispalmitate, Butyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide NG, Cetearyl Alcohol
Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 60, Propylene Glycol, Sodium Hyaluronate, Strontium Nitrate, Tocopherol Acetate (Vitamin E), Water, Xanthan Gum


Product Label




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