FDA Label for Dermend Moisturizing Anti-itch

View Indications, Usage & Precautions

Dermend Moisturizing Anti-itch Product Label

The following document was submitted to the FDA by the labeler of this product Ferndale Laboratories, Inc.. 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 HCl 1% w/w


Purpose



external analgesic


Use



for the temporary relief of itching associated with minor skin irritations


Warnings



For external use only.

Avoid contact with the eyes.


Stop Use And Ask A Doctor If



  • conditions worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.



If swallowed, seek medical attention or contact a Poison Cotrol Center right away.


Directions



  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Inactive Ingredients



cetyl alcohol, di-isopropyl adipate, dimethicone, glycerin, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), mineral oil, polyoxyl 40 stearate, potassium sorbate, povidone, purified water, sorbic acid, stearic acid, and trolamine


Package Label



NDC 0496-0586-08

8oz (237mL)


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