BURNX  PAIN RELIEVING BURN- lidocaine hydrochloride gel 
Natureplex, LLC

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.

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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

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)

Principal Display Panel - 28 g Tube Carton
BURNX   PAIN RELIEVING BURN
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
TEA TREE OIL (UNII: VIF565UC2G)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-037-011 in 1 CARTON04/10/2010
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34804/10/2010
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-037)

Revised: 10/2017
Document Id: da4b3275-2f1b-425a-8d98-d61d3a65b87b
Set id: 0558cdc9-8523-4dd5-baa5-9a8b0af46f8c
Version: 2
Effective Time: 20171024
 
Natureplex, LLC