Animal NDC 17033-123-75 Animax

Nystatin-neomycin Sulfate-thiostrepton-triamcinolone Acetonide

Animal NDC Product Code 17033-123-75

Field Name Field Value
Animal NDC Code 17033-123-75
Proprietary Name Animax 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 Nystatin-neomycin Sulfate-thiostrepton-triamcinolone Acetonide 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 Dechra Veterinary Products
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Triamcinolone Acetonide
  • Thiostrepton
  • Neomycin Sulfate
  • Nystatin
Inactive Ingredient(s)
  • SORBITOL (506T60A25R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • PETROLATUM (4T6H12BN9U)
  • POLYOXYL 40 STEARATE (13A4J4NH9I)
  • GLYCERYL MONOSTEARATE (230OU9XXE4)
  • TITANIUM DIOXIDE (15FIX9V2JP)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • ETHYLENEDIAMINE (60V9STC53F)
  • METHYLPARABEN (A2I8C7HI9T)
  • PROPYLPARABEN (Z8IX2SC1OH)
  • SORBITOL (506T60A25R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • PETROLATUM (4T6H12BN9U)
  • POLYOXYL 40 STEARATE (13A4J4NH9I)
  • GLYCERYL MONOSTEARATE (230OU9XXE4)
  • TITANIUM DIOXIDE (15FIX9V2JP)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • ETHYLENEDIAMINE (60V9STC53F)
  • METHYLPARABEN (A2I8C7HI9T)
  • PROPYLPARABEN (Z8IX2SC1OH)
Marketing Category ANADA - ABBREVIATED 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 ANADA200330 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.

Animax 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

Caution:

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

Description:

Animax Cream combines nystatin, neomycin sulfate, thiostrepton and
triamcinolone acetonide.

Each gram contains:

nystatin................................................................................................................ 100,000 units
neomycin sulfate equivalent to neomycin base................................................................ 2.5 mg
thiostrepton ............................................................................................................. 2,500 units
triamcinolone acetonide ................................................................................................... 1 mg


in an aqueous non-irritating vanishing cream base of
polyoxyethylene fatty alcohol ether, sorbitol solution, propylene
glycol, white petrolatum, polyoxyl 40 stearate, glyceryl
monostearate, titanium dioxide, citric acid, ethylenediamine,
methylparaben, propylparaben.

Actions:

By virtue of its four active ingredients, Animax Cream (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide cream USP) provides four basic
therapeutic effects: anti-inflammatory, antipruritic, antifungal and antibacterial. Triamcinolone
acetonide is a potent synthetic corticosteroid providing rapid and prolonged symptomatic relief
on topical administration. Inflammation, edema, and pruritis promptly subside, and lesions are
permitted to heal. Nystatin is the first well-tolerated antifungal antibiotic of dependable efficacy
for the treatment of cutaneous infections caused by Candida albicans (Monilia). Nystatin is
fungistatic in vitro against a variety of yeast and yeast-like fungi including many fungi pathogenic
to animals. No appreciable activity is exhibited against bacteria.
Thiostrepton has a high order of
activity against gram-positive organisms, including many which are resistant to other antibiotics;
neomycin exerts antimicrobial action against a wide range of gram-positive and gram-negative
bacteria. Together they provide comprehensive therapy against those organisms responsible for
most superficial bacterial infections.

Indications:

Animax Cream (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide cream USP)
is indicated in the management of dermatologic disorders in dogs and cats, characterized
by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or
threatened by bacterial or candidal (Candida albicans) infections. It is also of value in
eczematous dermatitis, contact dermatitis, and seborrheic dermatitis; and as an adjunct
in the treatment of dermatitis due to parasitic infestation.

Contraindications:

Animax Cream should not
be used ophthalmically.

Warnings:

Animax Cream is indicated for use in
dogs and cats only. Not for use in animals which are raised for food.

Absorption of triamcinolone acetonide through topical application
and by licking may occur. Therefore animals should be observed
closely for signs of polydipsia, polyuria and increased weight gain
particularly when the preparation is used over large areas or for
extended periods of time.

Clinical and experimental data have demonstrated that
corticosteroids administered orally or by injection to animals may
induce the first stage of parturition if used during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta and metritis.

Additionally, corticosteroids administered to dogs, rabbits and
rodents during pregnancy have resulted in cleft palate in
offspring. Corticosteroids administered to dogs during pregnancy
have also resulted in other congenital anomalies including
deformed forelegs, phocomelia and anasarca.

Precautions:

Animax Cream (Nystatin-Neomycin Sulfate-
Thiostrepton-Triamcinolone Acetonide Cream USP) is not
intended for the treatment of deep abscesses or deep-seated
infections such as inflammation of the lymphatic vessels.
Parenteral antibiotic therapy is indicated in these infections.
Nystatin-Neomycin Sulfate-Thiostrepton-Triamcinolone
Acetonide Cream USP has been extremely well tolerated. The
occurrence of systemic reactions is rarely a problem with topical
administration.

Sensitivity to neomycin may occur. If redness, irritation or
swelling persists or increases, discontinue use. Do not use if pus
is present since the drug may allow the infection to spread.

Avoid ingestion. Oral or parental use of corticosteroids,
depending on dose, duration and specific steroid, may result in
inhibition of endogenous steroid production following drug
withdrawal.

Side Effects:

SAP and SGPT (ALT) enzyme elevations,
polydipsia and polyuria have occurred following parenteral or
systemic use of synthetic corticosteroids in dogs. Vomiting and
diarrhea (occasionally bloody) have been observed in dogs.
Cushing's syndrome in dogs has been reported in association
with prolonged or repeated steroid therapy.

Dosage And Administration:

Frequency of administration
is dependent on the severity of the condition. For mild
inflammations, application may range from once daily to once a
week; for severe conditions Animax Cream may be applied as
often as 2 to 3 times daily, if necessary. Frequency of treatment
may be decreased as improvement occurs.

Clean affected areas, removing any encrusted discharge or
exudate. Apply Animax Cream (Nystatin-Neomycin Sulfate-
Thiostrepton-Triamcinolone Acetonide Cream USP) sparingly in a
thin film.

How Supplied:

Animax Cream (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide cream USP) is supplied in tubes as follows:

7.5 gram tubes NDC 17033-123-75
15 gram tubes NDC 17033-123-15

Storage:

Store at room temperature; avoid excessive heat (104°F).

To Open:

Use cap to puncture seal.

Important:

Do not use if seal has been punctured or
is not visible.

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