NDC 80214-005 Insect Repellent Insect Block

Deet - Di Ethyl Toluamide

NDC Product Code 80214-005

NDC 80214-005-01

Package Description: 200 mL in 1 TUBE

NDC Product Information

Insect Repellent Insect Block with NDC 80214-005 is a a human over the counter drug product labeled by Mod Design Build. The generic name of Insect Repellent Insect Block is deet - di ethyl toluamide. The product's dosage form is aerosol and is administered via topical form.

Labeler Name: Mod Design Build

Dosage Form: Aerosol - A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols).

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.

Insect Repellent Insect Block 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.

  • DIETHYLTOLUAMIDE 9 g/100mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTANE (UNII: 6LV4FOR43R)
  • ISOBUTANE (UNII: BXR49TP611)
  • PROPANE (UNII: T75W9911L6)

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: Mod Design Build
Labeler Code: 80214
Marketing Category: UNAPPROVED DRUG OTHER - 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: 03-23-2021 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Insect Repellent Insect Block Product Label Images

Insect Repellent Insect Block 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

Active Ingredient

DEET - 9%

Purpose

Insect repellent

Use

-Shake the Insect Block Aerosol well before use.


- Position the aerosol Insect Block at a distance of 15 cm from the body and the skin


evenly in slow and circular movements.


- Do not apply the product excessively.


- Protect your eyes during application.


- Do not apply under clothing.

Warnings

- Keep the product out of the reach of children and pets.


-Do not use if the skin is irritated or injured.


-Apply to exposed areas only when necessary.


- In case of intoxication and/or adverse reactions, suspend use and look for a poisoning center or


health service, taking an image of the package with the product label in its original packaging.


- Do not apply to the eyes, mouth, inner ears or nose.


-Watch your eyes, in case of contact with eyes, rinse immediately with plenty of running water.


-Do not store this product in a car.


-To apply on the face: apply first the product on the hands and then to the face, avoiding contact


with the eyes, mouth and nostrils.


- After use wash your hands with soap and water.


- The person will be protected for up to 4 hours and after this period.


  Reapply the product if necessary.


  Limit to only 3 daily applications.


 Caution: dangerous if swallowed do not induce vomiting.


 In case of emergency call or consult a doctor.


 Do not apply indoors.


 Avoid inhalation of the product.


 Do not use on children under 12 years.


 Flammable, do not spray near fire.


 Do not spray near a fire.


 Do not perforate or incinerate the container.


 Even when empty, do not expose to the sunlight or the temperature above 122°F and 5o°c.


 Careful content under pressure store in a cool ventilated environment.


 Consult a doctor for use during pregnancy and breastfeeding.


 Attention the use of repellents does not replace other measures to combat mosquito-borne diseases.

Inactive Ingredients

WATER, ACRYLATE$ COPOLYMER, DIETHYL TOLUAMIDE, ALCOHOL, CITRIC ACID, PERFUME, BENZYL


SALICYLATE, BENZYL BENZOATE, CITRONELLA, COUMARIN, GERANIOL, HEXYL CINNAMAL,


HYDROXYCITRONELLAL, LIMONENE, LINALOOL, BUTANE, ISOBUTANE, PROPANE, PHENOXYETHANOL,


METHYLPARABEN, PROPYLBARABEN, BUTYLPARABEN, ISOBUTYLPARABEN, GLYCERIN.

* Please review the disclaimer below.