NDC 26509-0201 Clorox Healthcare Aloeguard Antimicrobial

Chloroxylenol

NDC Product Code 26509-0201

NDC Code: 26509-0201

Proprietary Name: Clorox Healthcare Aloeguard Antimicrobial 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: Chloroxylenol 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

  • 26509 - The Clorox Company
    • 26509-0201 - Clorox Healthcare Aloeguard Antimicrobial

NDC 26509-0201-1

Package Description: 118 mL in 1 BOTTLE

NDC 26509-0201-2

Package Description: 532 mL in 1 BOTTLE

NDC 26509-0201-3

Package Description: 3785 mL in 1 BOTTLE

NDC 26509-0201-4

Package Description: 800 mL in 1 BAG

NDC Product Information

Clorox Healthcare Aloeguard Antimicrobial with NDC 26509-0201 is a a human over the counter drug product labeled by The Clorox Company. The generic name of Clorox Healthcare Aloeguard Antimicrobial is chloroxylenol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: The Clorox Company

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.

Clorox Healthcare Aloeguard Antimicrobial 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.

  • CHLOROXYLENOL 7.5 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.

  • COCO-BETAINE (UNII: 03DH2IZ3FY)
  • D&C GREEN NO. 8 (UNII: I2W85YOX9L)
  • OLEIC ACID (UNII: 2UMI9U37CP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • WATER (UNII: 059QF0KO0R)
  • COCONUT ACID (UNII: 40U37V505D)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MONOETHANOLAMINE (UNII: 5KV86114PT)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)

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: The Clorox Company
Labeler Code: 26509
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: 07-10-2019 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: 12-31-2020 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.

Clorox Healthcare Aloeguard Antimicrobial Product Label Images

Clorox Healthcare Aloeguard Antimicrobial 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

Chloroxylenol 0.75% w/w

Purpose

Antiseptic

Uses

  • For hand-washing to decrease microbes on the skinideal for daily repeated washings

Warnings

For external use only

Otc - When Using

  • When using this productdo not use in or near eyes
  • Discontue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

  • Wet handsapply product (palmful)wash hands vigorouslyrinse thoroughly

Other Information

  • Store at room temperatuurefor healthcare professional use only

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Coconut Fatty Acid, D&C Green No. 8, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Monoethanolamine, Oleic Acid, Propylene Glycol Sodium Sulfate, Tetrasodium EDTA, Water.

* Please review the disclaimer below.

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