Burnx
FDA Label NDC 67234-037

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natureplex, Llc for the product Burnx (NDC 67234-037). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - do not use, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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.

Otc - Do Not 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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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)

Principal Display Panel (28 g Tube Carton)

Principal Display Panel (28 g Tube Carton)

* Please review the disclaimer below.