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Unburn

Water-Jel Technologies

Water-Jel Unburn


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, carbomer, diazolidnyl urea, edetate disodium, glyceryl-7 stearate, methylparaben, octoxynol-9, polysorbate 20, propylene glycol, propylparaben, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate

1-800-275-3433

Monday - Friday (9a.m. - 5 p.m. EST)

www.unburn.info

Principle Display Panel

UnburnEnter section text here

Unburn

Lidocaine hydrochloride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59898-500
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
METHYLPARABEN
OCTOXYNOL-9
POLYSORBATE 20
propylene glycol
PROPYLPARABEN
water
spearmint oil
TEA TREE OIL
TROLAMINE
.ALPHA.-TOCOPHEROL ACETATE
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59898-500-10 59 in 1 BOTTLE, PLASTIC
2 NDC:59898-500-14 240 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-03-17


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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