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Unburn

Water-Jel Technologies

Unburn Spray


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Lidocaine HCl 2.5%

Purpose

External analgesic

Unburn Uses

for the temporary relief of pain associated with:

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

Warnings

For external use only

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

Keep out of the reach of children

If swallowed, get medical help or contact a 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 daily
  • children under 2 years of age: consult a doctor

Unburn Other information

  • store at 15o to 25oC (59o to 77oF)
  • 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

1-800-275-3433info@waterjel.com   www.waterjel.com

Principle Display Panel

Unburn

Unburn

Lidocaine hydrochloride SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59898-510
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE LIDOCAINE 2.5 g

Inactive Ingredients

Ingredient Name Strength
ALOE
CAPRYLIC ALCOHOL
CARBOMER HOMOPOLYMER TYPE C
CHLORPHENESIN
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
OCTOXYNOL-9
POLYSORBATE 20
PHENOXYETHANOL
water
spearmint oil
TEA TREE OIL
TROLAMINE
.ALPHA.-TOCOPHEROL ACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59898-510-45 150 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2014-02-01


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Be sure to consult your doctor before taking any medication!
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