NDC 0869-0248 Chest Rub

Camphor, Eucalyptus Oil, Menthol

NDC Product Code 0869-0248

NDC 0869-0248-17

Package Description: 50 g in 1 JAR

NDC 0869-0248-75

Package Description: 100 g in 1 JAR

NDC Product Information

Chest Rub with NDC 0869-0248 is a a human over the counter drug product labeled by Vi-jon, Llc. The generic name of Chest Rub is camphor, eucalyptus oil, menthol. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1442407.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Chest 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.


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)
  • TURPENTINE OIL (UNII: C5H0QJ6V7F)
  • THYMOL (UNII: 3J50XA376E)

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: Vi-jon, Llc
Labeler Code: 0869
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: 06-28-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Chest Rub Product Label Images

Chest 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

Other Safety Information

Failure to follow these warnings could result in serious consequences

Active Ingredients

Camphor 4.8%Eucalyptus oil 1.2%Menthol 2.6%

Purpose

Cough suppressant & topical analgesic

Uses

  • On chest and throat, temporarily relieves cough due to common coldon muscles and jonts, temporarily releives minor aches and pains

Warnings

For external use only; avoid contact with eyes

Do Not Use

  • By mouthwith tight bandagesin nostrilson wounds or damaged skin

Ask A Doctor Before Use

  • If you havecough that occurs with too much phlegm (mucus)persistent or chronic cough such as occurs with smoking, asthma or emphysema

When Using This Product

  • Do notheatmicrowaveadd 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 persist more than 7 days or come backcough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache.These could be signs of a serious condition

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

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

Directions

  • See imporatant warning under "When using this product"adults + children 2 yrs + over:rub a thick layer on chest + throat or rub on sore aching musclescover with warm, dry cloth if desiredkeep clothing loose about throat/chest to help vapors reach the nose/mouthrepeat up to three times per 24 hours or as directed by doctorchildren under 2 years of age: ask a doctor

Other Information

Store at room temperature

Inactive Ingredients

Cedarleaf oil, nutmeg oil, special petrolatum, spirits of turpentine, thymol

Information

The active ingredients in Swan Medicated Chest Rub work naturally by breathing in the medicated vapors to relieve coughing due to colds. Swan Medicated Chest Rub also relieves minor aches and pains.

Disclaimer

This product is not manufactred or distributed by Procter & Gamble, distributor of Vicks VapoRub

Adverse Reactions

Distributed by:Vi-Jon, LLCSt. Louis, MO 63114

* Please review the disclaimer below.