Blue Gel Anesthetic

Lidocaine Hcl, Tetracaine Hcl, Racepinephrine Hcl

Dermal Source, Inc.
Human Otc Drug
NDC 80069-013

Blue Gel Anesthetic also known as Lidocaine Hcl, Tetracaine Hcl, Racepinephrine Hcl is a human otc drug labeled by 'Dermal Source, Inc.'. National Drug Code (NDC) number for Blue Gel Anesthetic is 80069-013. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Blue Gel Anesthetic drug includes Lidocaine Hydrochloride - 50 mg/g Racepinephrine Hydrochloride - .1 mg/g Tetracaine Hydrochloride - 10 mg/g . The currest status of Blue Gel Anesthetic drug is Active.

Drug Information:

Drug NDC:	80069-013
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Blue Gel Anesthetic
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Lidocaine Hcl, Tetracaine Hcl, Racepinephrine Hcl
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Dermal Source, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	LIDOCAINE HYDROCHLORIDE - 50 mg/g RACEPINEPHRINE HYDROCHLORIDE - .1 mg/g TETRACAINE HYDROCHLORIDE - 10 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	07 Jun, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Dermal Source, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2603492
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	V13007Z41A 336096P2WE 5NF5D4OPCI
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Amide Local Anesthetic [EPC] Amides [CS] Antiarrhythmic [EPC] Ester Local Anesthetic [EPC] Esters [CS] Local Anesthesia [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
80069-013-01	28.3495 g in 1 BOTTLE, PLASTIC (80069-013-01)	07 Jun, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Blue Gel Anesthetic

Lidocaine Hcl, Tetracaine Hcl, Racepinephrine Hcl

Gel
Dermal Source, Inc.
NDC: 80069-013

Purpose:

Active ingredients (in each cc) purpose lidocaine hcl 5% topical anesthetic tetracaine hcl 1% topical anesthetic racepinephrine hcl 0.01% vasoconstrictor

Product Elements:

Blue gel anesthetic lidocaine hcl, tetracaine hcl, racepinephrine hcl lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous tetracaine hydrochloride tetracaine racepinephrine hydrochloride racepinephrine water diethylene glycol monoethyl ether propylene glycol hydroxyethyl cellulose, unspecified sodium metabisulfite epinephrine hydrochloride diazolidinyl urea edetate disodium anhydrous methylparaben propylparaben sodium citrate, unspecified form citric acid monohydrate fd&c yellow no. 5 fd&c blue no. 1 label

Indications and 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 have a history of severe liver disease or impairment a 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.

Do Not Use:

When Using:

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

Dosage and 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.

Stop Use:

Package Label Principal Display Panel:

Principal display panel new & improved blue gel anesthetic to reduce pain and swelling during pain sensitive procedures. 1 oz. distributed by: dermal source portland, or 97232 www.dermalsource.com 1-866-568-3223

Further Questions:

Questions? contact distributor on product label for further questions.

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.