NDC 61734-030 Vaporizing Colds Rub

Menthol

NDC Product Code 61734-030

NDC 61734-030-02

Package Description: 113 g in 1 JAR

NDC 61734-030-03

Package Description: 50 g in 1 JAR

NDC 61734-030-05

Package Description: 85 g in 1 BOTTLE, PUMP

NDC Product Information

Vaporizing Colds Rub with NDC 61734-030 is a a human over the counter drug product labeled by Delon Laboratories (1990) Ltd. The generic name of Vaporizing Colds Rub is menthol. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 200293.

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.

Vaporizing Colds 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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • CEDAR LEAF OIL (UNII: BJ169U4NLG)
  • THYMOL (UNII: 3J50XA376E)
  • TURPENTINE (UNII: XJ6RUH0O4G)

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: Delon Laboratories (1990) Ltd
Labeler Code: 61734
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: 05-24-2011 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 - 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".

* Please review the disclaimer below.

Vaporizing Colds 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 4.7%

Eucalyptus oil 1.2%

Menthol 2.6%

Purpose

Cough suppressant & topical analgesicCough suppressantCough suppressant & topical analgesic

Uses

  • Temporarily relieves:cough due to minor bronchial irritation associated with a cold or inhaled irritantscough associated with a coldminor aches and pains of muscles and joints

Do Not Use:

  • By mouthon wounds or damaged skinin nostrilswith tight bandages

Ask A Doctor Before Use If You Have

  • Excessive phlegm (mucus)emphysemapersistent or chronic coughasthmacough associated with smoking

When Using This Product, Do Not

  • Heatmicrowaveadd 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 dayscough perists 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.

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. 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 older:rub on the throat and chest in a thick layercover with a warm, dry cloth if desiredclothing should be loose about throat and chest to help vapors reach the nose and mouthuse up to three times daily or as directed by a doctorchildren under 2 years of age: ask a doctor

Other Information

  • Store at room temperature

Inactive Ingredients

Cedar leaf oil, petrolatum, thymol, turpentine

* Please review the disclaimer below.