NDC 73097-015 Vicks Vapo Rub

Camphor, Mentol, Eucalyptus Oil

NDC Product Code 73097-015

NDC Code: 73097-015

Proprietary Name: Vicks Vapo Rub 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: Camphor, Mentol, Eucalyptus Oil 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.

NDC Code Structure

  • 73097 - Savings Distributors Llc
    • 73097-015 - Vicks Vapo Rub

NDC 73097-015-01

Package Description: 12 g in 1 CONTAINER

NDC 73097-015-24

Package Description: 24 CONTAINER in 1 CARTON > 12 g in 1 CONTAINER

NDC Product Information

Vicks Vapo Rub with NDC 73097-015 is a a human over the counter drug product labeled by Savings Distributors Llc. The generic name of Vicks Vapo Rub is camphor, mentol, eucalyptus oil. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Savings Distributors Llc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 Vapo Rub 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.

  • CAMPHOR (SYNTHETIC) .048 g/g
  • EUCALYPTUS OIL .012 g/g
  • MENTHOL .026 g/g

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.

  • CEDAR LEAF OIL (UNII: BJ169U4NLG)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • THYMOL (UNII: 3J50XA376E)
  • TURPENTINE OIL (UNII: C5H0QJ6V7F)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Savings Distributors Llc
Labeler Code: 73097
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 07-22-2019 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 Vapo Rub Product Label Images

Vicks Vapo Rub 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 Ingredients

Camphor (synthetic) 4.8%Eucalyptus oil 1.2%Menthol 2.6%

Purpose

Cough suppressant & topical analgesicCough suppressantCough suppressant & topical analgesic

Uses

• when applied to chest or throat, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold• when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only; avoid contact with eyes.

Do Not Use

• by mouth • in nostrils• on wounds or damaged skin • with tight bandages

Ask A Doctor Before Use If You Have

• cough that occurs with too much phlegm (mucus)

• persistent or chronic cough such as occurs with smoking,
asthma or emphysema

When Using This Product Do Not

• heat • microwave

• add to hot water or any container where heating water.

May cause splattering and result in burns.

Stop Use And Ask A Doctor If

• muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days.

• cough persists for more than 1 week, tends to recur, or is
accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of The Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

See important warnings under “When using this product”
• adults and children 2 years and over:

• for cough suppression

• rub a thick layer on throat & chest

• cover with a warm, dry cloth if desired

• keep clothing loose about throat and chest to help vapors reach the
nose and mouth

• use up to three times daily or as directed by doctor

• for muscle / joint minor aches and pains apply to affected area not
more than 3 to 4 times daily

• children under 2 years: do not use

Other Information

• store at room temperature

Inactive Ingredients

Cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil.

* Please review the disclaimer below.

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