NDC 80069-009 Pro Plus

Lidocaine Hcl, Tetracaine Hcl

NDC Product Code 80069-009

NDC 80069-009-01

Package Description: 25.8768 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Pro Plus with NDC 80069-009 is a a human over the counter drug product labeled by Dermal Source, Inc.. The generic name of Pro Plus is lidocaine hcl, tetracaine hcl. The product's dosage form is cream and is administered via topical form.

Labeler Name: Dermal Source, Inc.

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.

Pro Plus 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 50 mg/29.5735mL
  • TETRACAINE HYDROCHLORIDE 10 mg/29.5735mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

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: Dermal Source, Inc.
Labeler Code: 80069
FDA Application Number: part346 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-10-2021 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: 12-31-2022 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.

Pro Plus Product Label Images

Pro Plus 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

Otc - Purpose

Active Ingredients (in each cc)PurposeLidocaine HCl 5%Topical AnestheticTetracaine HCl 1%Topical Anesthetic

Indications & Usage

Uses: External Use Only on Intact Skin. Temporarily relieves pain due to tattooing or other pain sensitive procedures.

Warnings

Warnings:Keep out of children's reach.Keep out of eyes and mouth. In case of accidental contact with eyes, rinse immediately with copious amounts of eyewash. Seek care by an eye care physician. If accidentally swallowed, get medical help immediately.

Otc - Do Not Use

  • Do not use:If you have a history of severe liver disease or impairment.If you have a known allergy or sensitivity to any of the components of this product. If sensitivity occurs, discontinue use and seek medical attention as needed. If condition worsens or does not improve in seven days, or clears up and occurs again within a few days, discontinue use of this product and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas.If pregnant or nursing.

Dosage & Administration

Directions:  Sensitivity test advised prior to use.Apply sparingly to affected area for 15-30 minutes or until anesthetic effect occurs. Remove and cleanse skin. Repeat as needed up to three times a day.

Inactive Ingredient

Inactive Ingredients: Purified Water, Glycerol Monostearate, Petrolatum, Stearic Acid, Cetyl Alcohol, Hydroxyethylcelluose, Triethanolamine, PEG 100 Stearate, Propyl Paraben, Methyl Paraben, and BHT.

Storage And Handling

Other information: Discard after expiration date. Store in cool, dark place.

Otc - Questions

Questions? Contact distributor on product label.

* Please review the disclaimer below.