Animal NDC 0010-4497-02 Acarexx

Ivermectin

Animal NDC Product Code 0010-4497-02

Field Name Field Value
Animal NDC Code 0010-4497-02
Proprietary Name Acarexx 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 Ivermectin 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.
Labeler Name Boehringer Ingelheim Vetmedica, Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Ivermectin
Inactive Ingredient(s)
  • HYDROGENATED SOYBEAN LECITHIN (H1109Z9J4N)
  • ALCOHOL (3K9958V90M)
  • CHOLESTEROL (97C5T2UQ7J)
  • .ALPHA.-TOCOPHEROL ACETATE (9E8X80D2L0)
  • BENZETHONIUM CHLORIDE (PH41D05744)
  • HYDROGENATED SOYBEAN LECITHIN (H1109Z9J4N)
  • ALCOHOL (3K9958V90M)
  • CHOLESTEROL (97C5T2UQ7J)
  • .ALPHA.-TOCOPHEROL ACETATE (9E8X80D2L0)
  • BENZETHONIUM CHLORIDE (PH41D05744)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION 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.
FDA Application Number NADA141174 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.

Acarexx Animal 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

NADA 141-174, Approved by FDA

Manufactured for:Boehringer Ingelheim Vetmedica, Inc.St. Joseph, MO 64506 U.S.A.Acarexx is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.© 2013 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.449701-02Code 449711Revised 07/20138366490983663228, R.1

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

Chemical name: Ivermectin is a mixture of 5-O-demethyl-22,23-dihydroavermectin A1a (component B1a) and 5-O-demethyl-25-de (1-methylpropyl)-22,23-dihydro-25-(1-methylethyl) avermectin A1b (component B1b). Empirical formula: B1a = C48H74O14, B1b = C47H72O14. Molecular weight: B1a = 875.10, B1b = 861.07.

Indications:

Acarexx (0.01% ivermectin) Otic Suspension is indicated for the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens four weeks of age or older. Effectiveness against eggs and immature stages has not been proven.

Dosage:

Acarexx suspension is administered topically in the ear canal at an ivermectin concentration of 0.01%. One dose of 0.5 mL is applied in each ear. Repeat treatment one time if necessary, based upon the ear mite life cycle and the response to treatment.

Administration:

Tear foil pouch at the notch to remove the two plastic ampules. Use one ampule per ear. Shake well before use. Snap off the cap of the ampule and place the tip into the external ear canal. Squeeze the entire contents of one ampule into the ear and massage the base of the ear to distribute the medication. Repeat the procedure in the other ear using the second ampule. In clinical field trials, ears were not cleaned and many animals still had debris in their ears at the end of the study. Cleaning the ears prior to administration of Acarexx suspension is not necessary to provide effectiveness.

Human Warnings:

Not for human use. Keep out of reach of children.

Precautions:

The safe use of Acarexx suspension in cats used for breeding purposes, during pregnancy, or in lactating queens, has not been evaluated.

Adverse Reactions:

In approximately 1% of 80 cats and kittens, pain associated with the pinna and vomiting were observed following treatment with Acarexx suspension.To report suspected adverse reactions, to obtain a Material Safety Data Sheet or for technical assistance, call 1-866-638-2226.

Effectiveness:

One treatment with Acarexx suspension was 92% effective in treating adult ear mite (Otodectes cynotis) infestations after seven days in a dose titration/confirmation study. In a well-controlled clinical field trial, one treatment of Acarexx suspension was 94% effective in clearing cats and kittens of adult ear mite infestations within 7 to 10 days.

Safety:

In two Target Animal Safety studies, Acarexx suspension was proven to be safe in kittens four weeks of age or older. Four-week-old kittens were administered Acarexx suspension at dose rates of 1X, 3X and 5X the recommended dose for three or six consecutive days and no adverse reactions were observed, except one kitten treated at 1X the dose had histologic evidence of minimal, chronic dermal inflammation of the ear. In a well-controlled clinical field trial, Acarexx suspension was used safely in cats and kittens receiving other frequently used veterinary products such as flea control products, vaccines, anthelmintics, antibiotics and steroids.

Storage:

Store below 77°F (25°C). Protect from freezing.

How Supplied:

Acarexx Otic Suspension is packaged in two polypropylene ampules per foil pouch, which are packaged 12 foil pouches per display carton. Each ampule is filled to deliver 0.5 mL of 0.01% ivermectin otic suspension per ear.

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.