NDC 0113-7005 Basic Care Nasal Allergy

Triamcinolone Acetonide

NDC Product Code 0113-7005

NDC CODE: 0113-7005

Proprietary Name: Basic Care Nasal Allergy 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: 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Triamcinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium- to strong-potency corticosteroid. The potency depends on the strength and the form that you use. For details on the potency of your product, ask your pharmacist.

NDC Code Structure

  • 0113 - L. Perrigo Company

NDC 0113-7005-01

Package Description: 1 BOTTLE in 1 CARTON > 120 SPRAY, METERED in 1 BOTTLE

NDC Product Information

Basic Care Nasal Allergy with NDC 0113-7005 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Nasal Allergy is triamcinolone acetonide. The product's dosage form is spray, metered and is administered via nasal form.

Labeler Name: L. Perrigo Company

Dosage Form: Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.

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.

Basic Care Nasal Allergy 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.

  • TRIAMCINOLONE ACETONIDE 55 ug/1

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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.
  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: ANDA078104 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: ANDA - A product marketed under an approved Abbreviated New 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.

Start Marketing Date: 04-25-2018 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.

Basic Care Nasal Allergy 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 (In Each Spray)

Triamcinolone acetonide 55 mcg (glucocorticoid)

Purpose

Allergy symptom reliever

Uses

  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: •nasal congestion •runny nose •sneezing •itchy nose

Do Not Use

  • •in children under 2 years of age •if you have ever had an allergic reaction to any of the ingredients

Ask A Doctor Before Use If You

  • •have had recent nose ulcers or nose surgery •have had a nose injury that has not healed •are using a steroid medicine for asthma, allergies or skin rash •have an eye infection •have or had glaucoma or cataracts

When Using This Product

  • •the growth rate of some children may be slower •some symptoms may get better on the first day of treatment. It may take up to one week of daily use to feel the most symptom relief. •do not share this bottle with anyone else as this may spread germs •remember to tell your doctor about all the medicines you take, including this one

Stop Use And Ask A Doctor If

  • •you have, or come into contact with someone who has, chickenpox, measles or tuberculosis •you have or develop symptoms of an infection such as a persistent fever •you have any change in vision •you have severe or frequent nosebleeds

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • Read insert (inside package) on how to: •get a new bottle ready (primed) before first use •prime bottle again if not used for more than 2 weeks •use the spray •clean the spray nozzleADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERadults and children 12 years of age and older •once daily, spray 2 times into each nostril while sniffing gently •once your allergy symptoms improve, reduce to 1 spray in each nostril per dayCHILDREN 2 TO UNDER 12 YEARS OF AGE •the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.children 6 to under 12 years of age •an adult should supervise use •once daily, spray 1 time into each nostril while sniffing gently •if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day.children 2 to under 6 years of age •an adult should supervise use •once daily, spray 1 time into each nostril while sniffing gentlychildren under 2 years of age •do not use •do not use more than directed •if you forget a dose, do not double the next dose •do not spray into eyes or mouth •if allergy symptoms do not improve after one week, stop using and talk to a doctor •do not use for the common cold •shake well before each use

Other Information

  • •do not use if printed bottle wrap is torn or opened •keep package and insert. They contain important information. •store between 20°-25°C (68°-77°F)

Inactive Ingredients

Benzalkonium chloride, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid or sodium hydroxide (for pH adjustment), microcrystalline cellulose, polysorbate 80, purified water

Consumer Information

  • Triamcinolone Acetonide Nasal Spray 55 mcg per sprayIMPORTANT INFORMATION •Read both sides of this insert for complete instructions on how to get a bottle ready (primed), how to use the spray bottle and how to clean the spray nozzle. •Keep this insert as it contains important information.STEPS TO GET A NEW BOTTLE READY FOR USE (PRIMED)1. Before first use, a new bottle must be primed.a.Remove cap and safety clip (Figure A).b.Shake bottle.c.Press and release spray nozzle until a fine mist is produced (as shown in Figure B). This may take several times. Take care not to spray in face.PRIME BOTTLE AGAIN IF NOT USED FOR MORE THAN 2 WEEKS •Repeat steps for priming a bottle (see above).USE INSTRUCTIONS1.Blow nose gently to clear nostrils.2.Remove cap and safety clip, then shake bottle.3.Hold bottle with thumb under bottle and spray nozzle between fingers (as shown in Figure B).4.Press against the outside of your nose with your finger to close off one nostril (as shown in Figure C).5.Place the tip of the spray nozzle into the other nostril. The spray nozzle should not reach far into the nose. Aim nozzle toward back of nose (as shown in Figure C).DO NOT spray toward nasal septum (the wall between the 2 nostrils) (as shown in Figure D). 6. While sniffing gently, spray into nostril.IMPORTANT: For complete dosing instructions, See “Directions for use” on next side. 7. Repeat steps “4” through “6” for the other nostril. 8. After using the nasal spray, wipe nozzle with a tissue, replace safety clip, and replace cap by pressing it down over the spray nozzle.NOTE: Avoid blowing nose for 15 minutes after use.If nozzle does not spray properly, see cleaning instructions on next side.(continued on side 2)SIDE 1DIRECTIONS FOR USE •BEFORE first use, you must get a new bottle ready (primed). •If bottle is not used for more than 2 weeks, prime bottle again.DosingADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERadults and children 12 years of age and older •once daily, spray 2 times into each nostril while sniffing gently •once your allergy symptoms improve, reduce to 1 spray in each nostril per dayCHILDREN 2 TO UNDER 12 YEARS OF AGE •the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.children 6 to under 12 years of age •an adult should supervise use •once daily, spray 1 time into each nostril while sniffing gently •if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day.children 2 to under 6 years of age •an adult should supervise use •once daily, spray 1 time into each nostril while sniffing gentlychildren under 2 years of age •do not useOther important information for use •Do not use more than directed. •If you forget a dose, do not double the next dose. •Do not spray into eyes or mouth. •If you get the spray in your eyes, rinse well with water. •If allergy symptoms do not improve after one week, stop using and talk to a doctor. •Do not share this bottle with anyone else as this may spread germs.IF PUMP DOES NOT SPRAY PROPERLY, THE NOZZLE MAY BE BLOCKED1.Never try to unblock nozzle with a pin or any other object (as shown in Figure E).2.Clean the nozzle as shown below.CLEANING INSTRUCTIONS1.Gently pull spray nozzle away from bottle (as shown in Figure F).2.Rinse SPRAY NOZZLE ONLY under warm water (as shown in Figure G).3.Shake or tap to remove excess water.4.Re-attach spray nozzle to bottle.5.Press and release spray nozzle until a fine spray is produced, taking care not to spray in face.Triamcinolone Acetonide Nasal Spray pump is now ready to use.Where can I get more information? 1-800-719-9260Store between 20°-25°C (68°-77°F)Made in IsraelDistributed ByPerrigo®Allegan, MI 49010SIDE 2: 44300 00 J4

* Please review the disclaimer below.