NDC 77302-004 Puricia Sanitizing Wipes (mint)

Ethyl Alcohol, Benzalkonium Chloride, Cetylpyridinium Chloride, Didecyl Dimethyl Ammonium Chloride, Chlorphenesin, Phenoxyethanol

NDC Product Code 77302-004

NDC CODE: 77302-004

Proprietary Name: Puricia Sanitizing Wipes (mint) 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: Ethyl Alcohol, Benzalkonium Chloride, Cetylpyridinium Chloride, Didecyl Dimethyl Ammonium Chloride, Chlorphenesin, Phenoxyethanol 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

NDC 77302-004-01

Package Description: 50 U in 1 BAG

NDC 77302-004-02

Package Description: 80 U in 1 CANISTER

NDC Product Information

Puricia Sanitizing Wipes (mint) with NDC 77302-004 is a a human over the counter drug product labeled by Pharmaberg Inc.. The generic name of Puricia Sanitizing Wipes (mint) is ethyl alcohol, benzalkonium chloride, cetylpyridinium chloride, didecyl dimethyl ammonium chloride, chlorphenesin, phenoxyethanol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Pharmaberg Inc.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Puricia Sanitizing Wipes (mint) 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.

  • ALCOHOL 65 U/100U
  • BENZALKONIUM CHLORIDE .13 U/100U
  • PHENOXYETHANOL .3 U/100U
  • DIDECYLDIMONIUM CHLORIDE .1 U/100U
  • CHLORPHENESIN .05 U/100U
  • CETYLPYRIDINIUM CHLORIDE .05 U/100U

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FRAGRANCE MINT ORC2000774 (UNII: G7LK3FFB99)
  • MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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: Pharmaberg Inc.
Labeler Code: 77302
FDA Application Number: part333A 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: 11-05-2020 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: 12-31-2021 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 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.

Puricia Sanitizing Wipes (mint) 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

Description

The Puricia Sanitizing Wipes are the easiest and the most convenient way to clean. The wipe's tough texture cleans and kills 99% of germs.

Directions For Use:

(Bag)

1. Open the flip.

2. Pull out wipes one by one & use.

3. Please reseal after use to prevent moisture loss.
(Canister)

1. Open the lid of the container. Tear open the foil

2. Thread first sheet in
CENTER of roll through slits in lid. Replace lid.

3. Pull out wipes one by one & use. Please reseal after use to prevent moisture loss

Storage:

Keep the bags tightly closed in a dry, cool and well-ventilated place. Recommended storage temperature: 0°C to 40°C.

Active Ingredients

Ethyl alcohol 65%

Benzalkonium Chloride 0.13%

Cetylpyridinium Chloride 0.05%

Didecyl Dimethyl Ammonium Chloride 0.10%

Chlorophenesin 0.05%

Phenoxyethanol 0.30%

Purpose

Antiseptic

Uses

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use. Do not push fingers through opening.

Warnings

For external use only: Hands. Do not use in the eyes.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets except with adult supervision.

Otc - Do Not Use

Read product label carefully before use.If you have a hypersensitivity to any of the components of the formula, do not use the product.

Otc - Ask Doctor

In case of eye contact ,rinse with water. If irritation develops, discontinue use. Consult doctor if irritation persists for more than 72 hours. If swallowed, seek medical attention or contact a Poison Control Center right away.

Storage And Handling

Keep wipes inside original packaging. Store unopened packages in a cool, dry place away from direct light inaccessible to small children.

After use, dispose the wipes in the trash. DO NOT flush in toilet.

Inactive Ingredient

Water, Citric Acid, Glycerol, Propylene Glycol, Matricaria recutita and Scent (Mint)

Dosage & Administration

Recommended for repeated use.

* Please review the disclaimer below.