Basic Care Childrens Allergy Relief Nasal
Fluticasone Propionate
Amazon.com Services Llc
Human Otc Drug
NDC 72288-333Basic Care Childrens Allergy Relief Nasal also known as Fluticasone Propionate is a human otc drug labeled by 'Amazon.com Services Llc'. National Drug Code (NDC) number for Basic Care Childrens Allergy Relief Nasal is 72288-333. This drug is available in dosage form of Spray, Metered. The names of the active, medicinal ingredients in Basic Care Childrens Allergy Relief Nasal drug includes Fluticasone Propionate - 50 ug/1 . The currest status of Basic Care Childrens Allergy Relief Nasal drug is Active.
Drug Information:
Drug NDC: | 72288-333 |
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
Proprietary Name: | Basic Care Childrens Allergy Relief Nasal |
Also known as the trade name. It is the name of the product chosen by the labeler. |
Product Type: | Human Otc Drug |
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
Non Proprietary Name: | Fluticasone Propionate |
Also known as the generic name, this is usually the active ingredient(s) of the product. |
Labeler Name: | Amazon.com Services Llc |
Name of Company corresponding to the labeler code segment of the ProductNDC. |
Dosage Form: | Spray, Metered |
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
Status: | Active |
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
Substance Name: | FLUTICASONE PROPIONATE - 50 ug/1
|
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
Route Details: | NASAL
|
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: | ANDA |
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
Marketing Start Date: | 20 Dec, 2021 |
This is the date that the labeler indicates was the start of its marketing of the drug product. |
Marketing End Date: | 16 Jan, 2025 |
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
Application Number: | ANDA207957 |
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. |
Listing Expiration Date: | 31 Dec, 2023 |
This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name: | Amazon.com Services LLC
|
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
RxCUI: | 1797907
|
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
Original Packager: | Yes
|
Whether or not the drug has been repackaged for distribution. |
UNII: | O2GMZ0LF5W
|
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC]
|
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
---|
72288-333-08 | 1 BOTTLE in 1 CARTON (72288-333-08) / 72 SPRAY, METERED in 1 BOTTLE | 20 Dec, 2021 | N/A | No |
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose allergy symptom reliever
Product Elements:
Basic care childrens allergy relief nasal fluticasone propionate fluticasone propionate fluticasone benzalkonium chloride dextrose, unspecified form microcrystalline cellulose phenylethyl alcohol polysorbate 80 water carboxymethylcellulose sodium, unspecified form
Indications and Usage:
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose itchy, watery eyes
Warnings:
Warnings only for use in the nose. do not spray into your eyes or mouth. do not use in children under 4 years of age to treat asthma if you have an injury or surgery to your nose that is not fully healed if you have ever had an allergic reaction to this product or any of the ingredients ask a doctor before use if you have or had glaucoma or cataracts ask a doctor or pharmacist before use if you are taking medicine for hiv infection (such as ritonavir) a steroid medicine for asthma, allergies or skin rash ketoconazole pills (medicine for fungal infection) when using this product the growth rate of some children may be slower stinging or sneezing may occur for a few seconds right after use 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, chicken pox, measles or tuberculosis
Read more... your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. you may have something more than allergies, such as an infection. you get a constant whistling sound from your nose. this may be a sign of damage inside your nose. you get an allergic reaction to this product. seek medical help right away. you get new changes to your vision that develop after starting this product 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).
Do Not Use:
Warnings only for use in the nose. do not spray into your eyes or mouth. do not use in children under 4 years of age to treat asthma if you have an injury or surgery to your nose that is not fully healed if you have ever had an allergic reaction to this product or any of the ingredients ask a doctor before use if you have or had glaucoma or cataracts ask a doctor or pharmacist before use if you are taking medicine for hiv infection (such as ritonavir) a steroid medicine for asthma, allergies or skin rash ketoconazole pills (medicine for fungal infection) when using this product the growth rate of some children may be slower stinging or sneezing may occur for a few seconds right after use 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, chicken pox, measles or tuberculosis your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. you may have something more than allergies, such as an infection. you get a constant whistling sound from your nose. this may be a sign of damage inside your nose. you get an allergic reaction to this product. seek medical help right away. you get new changes to your vision that develop after starting this product 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).
When Using:
When using this product the growth rate of some children may be slower stinging or sneezing may occur for a few seconds right after use 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
Dosage and Administration:
Directions read the quick start guide for how to: prime the bottle use the spray clean the spray nozzle shake gently before each use use this product only once a day do not use more than directed adults and children 12 years of age and older week 1 use 2 sprays in each nostril once daily week 2 through 6 months use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms after 6 months of daily use ask your doctor if you can keep using children 4 to 11 years of age the growth rate of some children may be slower while using this product. children should use for the shortest amount of time necessary to achieve symptom relief. talk to your childs doctor if your child needs to use the spray for longer than two months a year. an adult should supervise use use 1 spray in each nostril once daily children under 4 years of age do not use
Stop Use:
Stop use and ask a doctor if you have, or come into contact with someone who has, chicken pox, measles or tuberculosis your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. you may have something more than allergies, such as an infection. you get a constant whistling sound from your nose. this may be a sign of damage inside your nose. you get an allergic reaction to this product. seek medical help right away. you get new changes to your vision that develop after starting this product you have severe or frequent nosebleeds
Package Label Principal Display Panel:
Package/label principal display panel amazon basic care full prescription strength compare to childrens flonase ® allergy relief active ingredient childrens allergy relief nasal spray fluticasone propionate nasal spray 50 mcg per spray allergy symptom reliever (glucocorticoid)* 24 hour relief non-drowsy 24 hour relief of: itchy, watery eyes nasal congestion runny nose itchy nose sneezing ages 4 years & older 72 metered spray 0.38 fl oz (11.1 ml) * fluticasone propionate is a steroid medicine known as a glucocorticoid. childrens allergy relief nasal spray image
Further Questions:
Questions or comments? 1-800-719-9260