Herpecin Pain Relief

Allantoin, Benzethonium Chloride, Lidocaine Hcl

Focus Consumer Healthcare, Llc
Human Otc Drug
NDC 71687-4000

Herpecin Pain Relief also known as Allantoin, Benzethonium Chloride, Lidocaine Hcl is a human otc drug labeled by 'Focus Consumer Healthcare, Llc'. National Drug Code (NDC) number for Herpecin Pain Relief is 71687-4000. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Herpecin Pain Relief drug includes Allantoin - 2 g/100g Benzethonium Chloride - .2 g/100g Lidocaine Hydrochloride Anhydrous - 4 g/100g . The currest status of Herpecin Pain Relief drug is Active.

Drug Information:

Drug NDC:	71687-4000
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:	Herpecin Pain Relief
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:	Allantoin, Benzethonium Chloride, Lidocaine Hcl
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Focus Consumer Healthcare, Llc
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:	ALLANTOIN - 2 g/100g BENZETHONIUM CHLORIDE - .2 g/100g LIDOCAINE HYDROCHLORIDE ANHYDROUS - 4 g/100g
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:	OTC MONOGRAPH NOT FINAL
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:	11 Jun, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	11 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.
Application Number:	part348
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.
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:	Focus Consumer Healthcare, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2566834
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.
UPC:	0371687777333
UPC stands for Universal Product Code.
UNII:	344S277G0Z PH41D05744 EC2CNF7XFP
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] 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
71687-4000-1	1 TUBE in 1 CARTON (71687-4000-1) / 4 g in 1 TUBE	11 Jun, 2021	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

Herpecin Pain Relief

Allantoin, Benzethonium Chloride, Lidocaine Hcl

Gel
Focus Consumer Healthcare, LLC
NDC: 71687-4000

Purpose:

Skin protectant antiseptic topical anesthetic

Product Elements:

Herpecin pain relief allantoin, benzethonium chloride, lidocaine hcl hydroxyethyl cellulose, unspecified lysine hydrochloride, dl- ethylhexylglycerin lidocaine hydrochloride anhydrous lidocaine aloe vera leaf levomenol edetate disodium glycerin water ginger hydrolyzed jojoba esters (acid form) spearmint oil allantoin allantoin benzethonium chloride benzethonium melissa officinalis mentha piperita potassium hydroxide betasizofiran

Indications and Usage:

Uses â temporarily relieves pain and itching due to cold sores or fever blisters â temporarily relieves dryness; softens crusts (scabs) due to cold sores or fever blisters â first aid to help prevent infection in minor cuts, scrapes or burns due to cold sores or fever blisters

Warnings:

For external use only for external use only do not use do not use over large areas of the body or on deep or puncture wounds, animal bites or serious burns when using this product â keep out of eyes. rinse with water to remove. â apply only to the affected area. avoid applying directly inside the mouth. stop use and ask a doctor if rash occurs, or if condition worsens or symptoms persist more than 7 days or clear up and occur again in a few days keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.

Do Not Use:

When Using:

When using this product â keep out of eyes. rinse with water to remove. â apply only to the affected area. avoid applying directly inside the mouth.

Dosage and Administration:

Directions adults and children 12 years of age or older: â clean the affected area â apply externally to the lips 1 to 3 times daily children under 12 years of age: ask a doctor

Stop Use:

Stop use and ask a doctor if rash occurs, or if condition worsens or symptoms persist more than 7 days or clear up and occur again in a few days

Package Label Principal Display Panel:

Principal display panel maximum strength - new herpecin l pain relief triple action with lidocain tageted spot treatment for cold sores & fever blisters protects against infection numbs cold sore pain & itch at the source helps preven cracking cold sore pain reliever/antiseptic/lop protectant gel net wt 0.15oz (4g) herpecin pain

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.