NDC 16864-682 Dermoplast Insect Itch And Sting Relief

Benzocaine And Levomenthol

NDC Product Code 16864-682

NDC CODE: 16864-682

Proprietary Name: Dermoplast Insect Itch And Sting Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzocaine And Levomenthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 16864 - Advantice Health, Llc
    • 16864-682 - Dermoplast Insect Itch And Sting Relief

NDC 16864-682-01

Package Description: 78 g in 1 CAN

NDC Product Information

Dermoplast Insect Itch And Sting Relief with NDC 16864-682 is a a human over the counter drug product labeled by Advantice Health, Llc. The generic name of Dermoplast Insect Itch And Sting Relief is benzocaine and levomenthol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Advantice Health, Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Dermoplast Insect Itch And Sting 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.

  • BENZOCAINE 200 mg/g
  • LEVOMENTHOL 5 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.

  • PEG-8 LAURATE (UNII: 762O8IWA10)
  • POLYSORBATE 85 (UNII: A7F3N56197)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
  • CETYL ACETATE (UNII: 4Q43814HXS)
  • BUTANE (UNII: 6LV4FOR43R)
  • 1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)

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: Advantice Health, Llc
Labeler Code: 16864
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: 05-15-2021 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".

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Dermoplast Insect Itch And Sting Relief Product Label Images

Dermoplast Insect Itch And Sting 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

Other

Drug Facts

Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927

Otc - Purpose

Active ingredientsPurposeBenzocaine 20%Topical analgesicMenthol 0.5%Topical analgesic

Uses

  • For temporary relief of pain and itching associated withsunburninsect bitesminor cutsscrapesminor burnsminor skin irritations

Warnings

For external use onlyFlammable do not use near heat, flame, or fire or while smoking

Allergy Alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

When Using This Product

  • Avoid contact with eyes. Do not spray in the face or mouth.use only as directedintentional misuse by deliberately concentrating or inhaling the contents can be harmful or fataldo not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop Use And Ask A Doctor If

  • Condition worsens or symptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysitching, rash or irritation develops

Otc - Keep Out Of Reach Of Children

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

Directions

  • Adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times dailyChildren under 2 years of ageconsult a doctorto use this product, hold the can 6 to 12 inches away from the affected area. Direct spray nozzle towards skin and press button to activate spray.to apply to face, spray in palm of hand and gently apply

Other Information

  • Avoid contact with leather, fabric and upholstery to prevent possible staining or discolorationstore at 20-25°C (68-77°F)

Inactive Ingredients

Acetylated lanolin alcohol, aloe vera gel (decolorized), butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben, PEG-400 monolaurate, polysorbate 85

Questions?

1-800-345-0032Mon - Fri 8AM- 5PM ESTDermoplast.com

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