NDC 67234-037 Burnx Pain Relieving Burn

Lidocaine Hydrochloride

NDC Product Code 67234-037

NDC 67234-037-01

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Burnx Pain Relieving Burn with NDC 67234-037 is a a human over the counter drug product labeled by Natureplex, Llc. The generic name of Burnx Pain Relieving Burn is lidocaine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Natureplex, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Burnx Pain Relieving Burn Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LIDOCAINE HYDROCHLORIDE .025 g/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Natureplex, Llc
Labeler Code: 67234
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-10-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Burnx Pain Relieving Burn Product Label Images

Burnx Pain Relieving Burn Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling 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 worsenssymptoms persist for more than 7 days or clear up and occurs again within a few daysrash 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 dailyChildren 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

* Please review the disclaimer below.