NDC 62011-0075 Medicated Chest

Camphor, Eucalyptus Oil, Menthol

NDC Product Code 62011-0075

NDC 62011-0075-1

Package Description: 1 JAR in 1 PACKAGE > 100 g in 1 JAR

NDC Product Information

Medicated Chest with NDC 62011-0075 is a a human over the counter drug product labeled by Swinton Avenue Trading Ltd, Inc. The generic name of Medicated Chest is camphor, eucalyptus oil, menthol. The product's dosage form is jelly and is administered via topical form.

Labeler Name: Swinton Avenue Trading Ltd, Inc

Dosage Form: Jelly - A class of gels, which are semisolid systems that consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water.

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.

Medicated Chest 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) 48 mg/g
  • EUCALYPTUS OIL 12 mg/g
  • MENTHOL 26 mg/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)
  • 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.
  • 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: Swinton Avenue Trading Ltd, Inc
Labeler Code: 62011
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: 02-17-2020 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: 12-31-2021 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’.

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Medicated Chest Product Label Images

Medicated Chest 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

Otc - Active Ingredient

Active ingredientsCamphor 4.8%Eucalyptus oil 1.2%Menthol 2.6%

Otc - Purpose

PurposeCough suppressant + topical analgesicCough suppressantCough suppressant + topical analgesic

Indications & Usage

Uses•on chest + throat, temporarily relieves cough due to the common cold•on muscles and joints, temporarily relieves minor aces and pains

Warnings

WarningsFor external use only; avoid contact with eyes.

Otc - Do Not Use

Do not use•by mouth •with tight bandages •in nostrils •on wounds or damaged skin

Otc - Ask Doctor

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 emphusema

Otc - When Using

When using this product do not•heat •microwave •add to hot water or any container when heatingMay cause splattering and result in burns.

Otc - Stop Use

Stop use and ask a doctor if•muscle aches and pains persist more than 7 days or come back•cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.These could be signs of serious condition.

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

Dosage & Administration

DirectionsSee important warnings under "When using this product"•adults + children 2 yrs + over:•rub a thick layer on chest + throat or rub on sore aching muscles•cover with a warm, dry cloth if desired•keep clothing loose about throat/chest to help vapors reach the nose/mouth•repeat up to three times per 24 hours or as directed•children under 2 years of age: ask a doctor

Other Safety Information

Other information •store at room temperature

Inactive Ingredient

Inactive ingredients cedar leaf oil, nutmeg oil, special petrolatum, spirits of turpentine, thymol

Other

This product is not manufactured or distributed by Procter + Gamble, distributor of Vick's VapoRub

Adverse Reactions

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* Please review the disclaimer below.