NDC 67234-052 Proplex Lidocaine

Lidocaine

NDC Product Code 67234-052

NDC Product Information

Proplex Lidocaine with NDC 67234-052 is a a human over the counter drug product labeled by Natureplex Llc. The generic name of Proplex Lidocaine is lidocaine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Natureplex Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.


Proplex Lidocaine 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 4 g/100g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARGININE (UNII: 94ZLA3W45F)
  • SULISOBENZONE (UNII: 1W6L629B4K)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
  • ANGOPHORA COSTATA WHOLE (UNII: O5MY197D8F)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • WATER (UNII: 059QF0KO0R)
  • JOJOBA OIL (UNII: 724GKU717M)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)

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: 03-18-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Proplex Lidocaine Product Label Images

Proplex Lidocaine 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 4%

Purpose

Topical analgesic

Use

For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, 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 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

Aloe barbadensis leaf juice, arginine, benzophenone-4, caprylyl glycol, cetyl alcohol, dimethyl sulfoxide, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, potassium sorbate, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

* Please review the disclaimer below.

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