FDA Label for Unburn

View Indications, Usage & Precautions

Unburn Product Label

The following document was submitted to the FDA by the labeler of this product Water-jel Technologies. 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 HCl 2.5%


Purpose



External analgesic


Uses



for the temporary relief of pain associated with:

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

Warnings



For external use only


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

Other Information



  • store at 15 o to 25 oC (59 o to 77 oF)
  • do not freeze
  • you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive Ingredients



acrylates/C20-30 alkyl acrylate crosspolymer, aloe, caprylyl glycol, carbomer, chlorophenesin, edetate disodium, glyceryl-7 stearate,  octoxynol-9, polysorbate 20, phenoxyethanol, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate


Otc - Questions



[email protected]   www.waterjel.com


* Please review the disclaimer below.