NDC 10742-0003 Mentholatum Greaseless Vaporizing Cream

Camphor, Eucalyptus Oil, Menthol

NDC Product Code 10742-0003

NDC Code: 10742-0003

Proprietary Name: Mentholatum Greaseless Vaporizing Cream 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, Eucalyptus Oil, Menthol 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

  • 10742 - The Mentholatum Company
    • 10742-0003 - Mentholatum Greaseless Vaporizing Cream

NDC 10742-0003-1

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE

NDC Product Information

Mentholatum Greaseless Vaporizing Cream with NDC 10742-0003 is a a human over the counter drug product labeled by The Mentholatum Company. The generic name of Mentholatum Greaseless Vaporizing Cream is camphor, eucalyptus oil, menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: The Mentholatum Company

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.

Mentholatum Greaseless Vaporizing Cream 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 (NATURAL) 53 mg/g
  • EUCALYPTUS OIL 13 mg/g
  • MENTHOL, UNSPECIFIED FORM 28 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.

  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
  • MAGNESIUM ALUMINUM SILICATE TYPE IA (UNII: SUS08ZOA9S)
  • OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: The Mentholatum Company
Labeler Code: 10742
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: 07-15-2019 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.

Mentholatum Greaseless Vaporizing Cream Product Label Images

Mentholatum Greaseless Vaporizing Cream 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 5.3%Eucalyptus oil 1.3%Menthol 2.8%

Purpose

Camphor – Cough suppressant / topical analgesicEucalyptus oil – Cough suppressantMenthol – Cough suppressant / topical analgesic

Keep Out Of Reach Of Children

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

Uses

  • •temporarily relieves cough due to minor throat and bronchial irritation associated with a cold •temporarily relieves cough to help you sleep •temporarily relieves minor aches and pains of muscles and joints

Warnings

  • For external use onlyAsk a doctor before use if you have •cough that occurs with too much phlegm (mucus) •chronic cough that lasts or as occurs with smoking, asthma, or emphysemaWhen using this product •do not heat, microwave, or add to hot water or any container where heating water. May cause splattering and result in burns •do not take by mouth or place in nostrils •do not bandage tightly •do not get into eyes •do not apply to wounds or damaged skinStop use and ask a doctor if •cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. •muscle aches and pains persist for more than 7 days or clear up and occur again with a few days

Directions

  • •see important warnings under "When using this product" •adults and children 2 years and over: •for cough suppression - •rub a thick layer on the throat and chest •cover with a warm, dry cloth if desired •keep clothing loose about the throat and chest to help vapors reach the nose and mouth •use up to 3 times daily or as directed by a doctor •for muscle / joint minor aches and pains apply to affected area not more than 3 to 4 times daily •children under 2 years : ask a doctor

Inactive Ingredients

Carbomer homopolymer, cetyl alcohol, chlorphenesin, cyclopentasiloxane, dimethicone crosspolymer-3, fragrance, glycerin, hydrogenated polyisobutene, hydrolyzed wheat protein/PVP crosspolymer, magnesium aluminum silicate, oleth-3 phosphate, phenoxyethanol, purified water, stearic acid, trolamine

* Please review the disclaimer below.

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