NDC 37000-928 Vicks Vapocool Sore Throat

Benzocaine And Menthol

NDC Product Code 37000-928

NDC 37000-928-06

Package Description: 177 mL in 1 BOTTLE, PUMP

NDC Product Information

Vicks Vapocool Sore Throat with NDC 37000-928 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Vicks Vapocool Sore Throat is benzocaine and menthol. The product's dosage form is liquid and is administered via oral form.

Labeler Name: The Procter & Gamble Manufacturing Company

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.


Vicks Vapocool Sore Throat 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.

  • BENZOCAINE 5 g/100mL
  • MENTHOL 1 g/100mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALCOHOL (UNII: 3K9958V90M)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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: The Procter & Gamble Manufacturing Company
Labeler Code: 37000
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: 04-24-2019 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.

Vicks Vapocool Sore Throat Product Label Images

Vicks Vapocool Sore Throat 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

Drug Facts

Made in Canada

Distributed by

Procter & Gamble,

Cincinnati, OH 45202

Active Ingredients (In Each 15 Ml)

Benzocaine (5 %)

Menthol (1 %)

Purpose

Oral anestheticOral anesthetic

Uses

  • Temporarily relieves occasional minor irritation and pain due tosore throatsore mouth

Methemoglobinemia Warning –

  • Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:pale, gray or blue colored skin (cyanosis)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energy

Allergy Alert:

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

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 12 years of age.

Do Not Use

  • For teethingin children under 2

When Using This Product

Do not exceed recommended dosage

Ask A Doctor Before Use If You Have

  • A severe sore throat accompanied by difficulty in breathing or that lasts more than 2 daysa sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

Stop Use And Ask A Doctor If

  • Sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

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

Directions

  • Adults and children 12 years and over: Apply to the affected area (one spray). Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a doctor.children under 12 years, do not use.

Other Information

  • Do not exceed 25ºC. Do not refrigerate.

Inactive Ingredients

Alcohol, D&C Yellow No. 10, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sucralose

Questions?

1-800-283-4879

* Please review the disclaimer below.

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