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BurnX Pain Relieving Burn

Medically reviewed on October 24, 2017

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 0.025g in 1g
Labeler: Natureplex, LLC
NDC Code: 67234-037

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.

BurnX™
PAIN RELIEVING BURN GEL

Drug Facts

Active Ingredient

Lidocaine hydrochloride 2.5%

Purpose

Topical analgesic

Use

for the temporary relief of pain associated with minor burns, sunburn, and minor skin irritations

Warnings

For external use only.

Avoid contact with eyes.

Not for prolonged use.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • rash or irritation develops, persists, or increases

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

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 to 30° C (59 to 86° F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

Carbomer, disodium EDTA, glycerin, melaleuca alternifolia (tea tree) leaf oil, octoxynol-9, propylene glycol (and) diazolidinyl urea (and) methylparaben (and) propylparaben, purified water, triethanolamine

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Natureplex

PAIN RELIEVING BURN GEL
NDC 67234-037-01

BurnX
LIDOCAINE HCL 2.5%
Topical Analgesic

For Burns and
Sunburns

NET WT. 1 Oz.(28g)

BURNX   PAIN RELIEVING BURN
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-037
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE 
EDETATE DISODIUM ANHYDROUS 
TEA TREE OIL 
OCTOXYNOL-9 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
TROLAMINE 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:67234-037-011 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34804/10/2010
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIOperations
Natureplex LLC062808196MANUFACTURE(67234-037)

 
Natureplex, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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