NDC 71687-4000 Herpecin Pain Relief

Allantoin, Benzethonium Chloride, Lidocaine Hcl

NDC Product Code 71687-4000

NDC 71687-4000-1

Package Description: 1 TUBE in 1 CARTON > 4 g in 1 TUBE

NDC Product Information

Herpecin Pain Relief with NDC 71687-4000 is a a human over the counter drug product labeled by Focus Consumer Healthcare, Llc. The generic name of Herpecin Pain Relief is allantoin, benzethonium chloride, lidocaine hcl. The product's dosage form is gel and is administered via topical form.

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.

Herpecin Pain Relief 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.


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.

  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • LYSINE HYDROCHLORIDE, DL- (UNII: 81478P92RJ)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • GINGER (UNII: C5529G5JPQ)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • MELISSA OFFICINALIS (UNII: YF70189L0N)
  • MENTHA PIPERITA (UNII: 79M2M2UDA9)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)

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: Focus Consumer Healthcare, Llc
Labeler Code: 71687
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: 06-11-2021 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.

Herpecin Pain Relief 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 - Active Ingredient

Allantoin 2%

Benzethonium chlroide 0.2%

Lidocaine HCl 4%

Otc - Purpose

Skin ProtectantAntisepticTopical Anesthetic

Uses

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

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

■ keep out of eyes. Rinse with water to remove.■ apply only to the affected area. Avoid applying directly inside the mouth.

Otc - 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age or older:■ clean the affected area■ apply externally to the lips 1 to 3 times dailychildren under 12 years of age: Ask a doctor

Other Information

■ protect this product from excessive heat and direct sun■ keep this carton as it contains important information

Inactive Ingredient

Aloe barbadensis leaf juice, bisabolol, disodium EDTA, ethylhexylglycerin, glycerin, hydrolyzed jojoba esters, hydroxyethylcellulose, lysine HCl, melissa officinalis extract, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil, potassium hydroxide, sclerotium gum, water, zingiber officinale (ginger) root extract

* Please review the disclaimer below.