NDC 0295-9355 Chloraseptic Sore Throat (kids Grape) Grape

Phenol

NDC Product Code 0295-9355

NDC 0295-9355-23

Package Description: 177 mL in 1 BOTTLE, SPRAY

NDC Product Information

Chloraseptic Sore Throat (kids Grape) Grape with NDC 0295-9355 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Chloraseptic Sore Throat (kids Grape) Grape is phenol. The product's dosage form is spray and is administered via oral form.

Labeler Name: Denison Pharmaceuticals, Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Chloraseptic Sore Throat (kids Grape) Grape 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.

  • PHENOL 3.5 mg/.7mL

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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Denison Pharmaceuticals, Llc
Labeler Code: 0295
FDA Application Number: part356 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: 03-07-2019 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.

Chloraseptic Sore Throat (kids Grape) Grape Product Label Images

Chloraseptic Sore Throat (kids Grape) Grape 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

Phenol 0.5%

Purpose

Oral Anesthetic/Analgesic

Uses

For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

Warnings

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

When Using This Product

Do not exceed recommended dosage.

Stop Use And Ask A Doctor Or Dentist If

  • Sore mouth symptoms do not improve in 7 days
  • Irritation, pain or redness persists or worsens
  • Swelling, rash or fever developsIf pregnant or breast-feeding, ask a health care professional before use.

Keep Out Of Reach Of Children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 3 years of age and older:Apply to the affected area (one spray).
  • Allow to remain in place for at least 15 seconds, then spit out.
  • Use every 2 hours or as directed by a doctor or dentist.
  • Children under 12 years of age should be supervised in the use of this product.
  • Children under 3 years of age: consult a doctor or dentist.

Other Information

  • Store at room temperature.
  • Check expiration date before using.

Inactive Ingredients

FD&C blue no. 1, FD&C red no.40, flavor, glycerin, purified water, sodium saccharin, sodium chloride

Questions?

1-800-552-7932 www.chloraseptic.com

* Please review the disclaimer below.