NDC 80069-008 Blue Gel Anesthetic

Lidocaine Hcl, Tetracaine Hcl, Epinephrine

NDC Product Code 80069-008

NDC 80069-008-01

Package Description: 28.3495 g in 1 BOTTLE, PLASTIC

NDC Product Information

Blue Gel Anesthetic with NDC 80069-008 is a a human over the counter drug product labeled by Dermal Source, Inc.. The generic name of Blue Gel Anesthetic is lidocaine hcl, tetracaine hcl, epinephrine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Dermal Source, Inc.

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.

Blue Gel Anesthetic 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/g
  • TETRACAINE HYDROCHLORIDE 10 mg/g
  • EPINEPHRINE 1 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: 04-01-2021 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.

Blue Gel Anesthetic Product Label Images

Blue Gel Anesthetic 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 Ingredient (in each cc)PurposeLidocaine HCl 5%Topical AnestheticTetracaine HCl 1%Topical AnestheticEpinephrine 0.1%Vasoconstrictor

Indications & Usage

Uses: External Use Only. Temporarily relieves pain and swelling due to tattooing, permanent makeup or other pain sensitive procedures.

Warnings

  • Warnings: Avoid contact with eyes.Do not swallow.     Keep out of children's reach.Do not use if you haveA history of severe liver disease or impairmentA known allergy or sensitivity to any of the components of this product.If sensitivity occurs, consult a doctor if condition worsens or does not improve in seven days, or clears up and occurs again within a few days. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Otc - Do Not Use

Do not use if pregnant or nursing. 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 - When Using

  • When using this product You may notice temporary blanching, skin irritation or sensitivity of the skin where gel is appliedYou may not have pain - avoid sources of heat or injuryYou may have delayed swelling after drug is dissipated

Dosage & Administration

Directions:  Sensitivity test advised prior to use.Apply sparingly to broken skin and cover with occlusive dressing. Product is ineffective when applied to intact skin. Wait until anesthetic effect occurs (2-5 minutes). Remove product before continuing with your procedure.

Inactive Ingredient

Inactive Ingredients: Purified Water, Ethoxydiglycol, Propylene Glycol, Hydroxyethylcellulose, Sodium Metabisulfite, Diazolidinyl Urea, Disodium EDTA, Methyl Paraben, Propyl Paraben, Sodium Citrate, Citric Acid, FD&C Yellow 5, and FD&C Blue 1.

Storage And Handling

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

Otc - Questions

Questions? Contact distributor on product label for further questions.

* Please review the disclaimer below.