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Unburn by Water-Jel Technologies

Dosage form: spray
Ingredients: LIDOCAINE HYDROCHLORIDE 2.5g in 100mL
Labeler: Water-Jel Technologies
NDC Code: 59898-510

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Unburn Spray

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

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

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

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

Principle Display Panel

UNBURN 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-510
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:59898-510-45150 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2014
Labeler - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIOperations
Water-Jel Technologies155522589manufacture(59898-510)

 
Water-Jel Technologies

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Medically reviewed on Nov 30, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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