NDC 51774-003 Puriderm Antibacterial

Benzalkonium Chloride

NDC Product Code 51774-003

NDC 51774-003-08

Package Description: 240 mL in 1 BOTTLE

NDC 51774-003-12

Package Description: 360 mL in 1 BOTTLE

NDC 51774-003-16

Package Description: 480 mL in 1 BOTTLE

NDC 51774-003-28

Package Description: 3785 mL in 1 BOTTLE

NDC Product Information

Puriderm Antibacterial with NDC 51774-003 is a a human over the counter drug product labeled by Industrias Chamer S.a. De C.v.. The generic name of Puriderm Antibacterial is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Industrias Chamer S.a. De C.v.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Puriderm Antibacterial 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.

  • BENZALKONIUM CHLORIDE 1 mg/mL

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.

  • COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

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: Industrias Chamer S.a. De C.v.
Labeler Code: 51774
FDA Application Number: part333E 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: 08-24-2020 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.

Puriderm Antibacterial 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

Active Ingredient

Benzalkonium chloride

Purpose

Antibacterial

Directions

Pump into hands. Massage throughly for at least 20 seconds. Rinse and dry throughly.

Warnings

External use only.

Otc - When Using

When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not use on irritated skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children if swallowed, get medical help.

Otc - Stop Use

Stop use and ask a doctor if irritation or redness develops and lasts more than 72 hours.

Inactive Ingredients

Aqua (Water), Sodium Laureth Sulfate, Sodium chloride, Cocamidopropyl Betaine, Cocamidopropyl PG Dimonium Chloride, Lauryl Glucoside, Glycerin, Parfum (Fragance), Aloe Barbadensis Extract, Tetrasodium EDTA, Citric Acid, Methylchloroisothiazolinone (and) Methylisothiazolinone, CI 42090, CI 19140, CI 17200.

Questions?

M-F: 8-5 CT+1 781 519-4494

* Please review the disclaimer below.