FDA Label for Simplicity Desensitizing

View Indications, Usage & Precautions

Simplicity Desensitizing Product Label

The following document was submitted to the FDA by the labeler of this product Simplicity Laser, 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:



Lidocaine 4% w/w


Purpose




Topical anesthetic


Use:



temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites

Warnings:



For external use only.


Otc - When Using



  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use And Ask Doctor If



  • Allergic reaction occurs
  • Condition worsens or does not improve within 7 days
  • Symptoms clear up and return within a few days
  • Redness, irritation, swelling, pain or other symptoms begin or increase

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions:



  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: Consult a doctor.

Other Information



Store at USP controlled room temperature 20-25 deg.C (68-77 deg.F).


Inactive Ingredients



Ag,carbomer 940, deionized water


Simplicity Desensitizing Gel, 1 Fl Oz/30Ml (69109-004-30)




* Please review the disclaimer below.