NDC 82355-550 Benzalkonium Chloride

Sanitizing Hand Wipes

NDC Product Code 82355-550

NDC 82355-550-01

Package Description: 20 PACKAGE in 1 PACKAGE > 1 mg in 1 PACKAGE

NDC 82355-550-02

Package Description: 20 PACKAGE in 1 PACKAGE > 1 mg in 1 PACKAGE

NDC Product Information

Benzalkonium Chloride with NDC 82355-550 is a a human over the counter drug product labeled by Alo New York Llc. The generic name of Benzalkonium Chloride is sanitizing hand wipes. The product's dosage form is cloth and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1038558.

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.

Benzalkonium Chloride 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.

  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MENTHA PIPERITA (UNII: 79M2M2UDA9)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

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: Alo New York Llc
Labeler Code: 82355
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: 12-21-2021 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.

Benzalkonium Chloride 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 Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

  • For hand sanitizing to decrease bacteria on the skinrecommended for repeated use

Warnings

For external use only.

Do Not Use

If you are allergic to any of these ingredients.

When Using This Product

Avoid contact with eyes. In case of contact, flush eyes with water.

Stop Use And Ask A Doctor

If irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out Of The Reach Of Children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

  • Adults and children 2 years and over: apply to hands: allow to dry without wipingchildren under 2 years: ask a doctor before use.To dispense: Peel back fron label slowly. Remove wipes.
  • To reseal: Firmly rub thumb over label. Dispose of wipe in trash. Do not flush.

Other Information

  • Store below 95store below 95°F (35°C).keep closed tightlymay discolor certain fabrics or surfaces.

Inactive Ingredients

Purified Water, Decyl Glucoside, Aloe Barbadensis (Aloe) Leaf Extract, Phenoxyethanol, Citric Acid, Sodium Benzoate, Potassium Sorbate, Eucalyptus Globulus Oil, Mentha Piperita (Peppermint) Oil.

* Please review the disclaimer below.