NDC 11527-083 Dr. Sheffield Vapor Cream

Vapor Cream

NDC Product Code 11527-083

NDC 11527-083-54

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Dr. Sheffield Vapor Cream with NDC 11527-083 is a a human over the counter drug product labeled by Sheffield Pharmaceuticals Llc. The generic name of Dr. Sheffield Vapor Cream is vapor cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Sheffield Pharmaceuticals Llc

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.

Dr. Sheffield Vapor 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 (SYNTHETIC) 52 mg/g
  • EUCALYPTUS OIL 12 mg/g
  • MENTHOL 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 940 (UNII: 4Q93RCW27E)
  • CEDAR LEAF OIL (UNII: BJ169U4NLG)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • IMIDUREA (UNII: M629807ATL)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • THYMOL (UNII: 3J50XA376E)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)

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: Sheffield Pharmaceuticals Llc
Labeler Code: 11527
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 08-01-2013 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.

Dr. Sheffield Vapor 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  5.2%Eucalyptus Oil  1.2%Menthol 2.8%

Purpose

Cough suppressant and topical analgesicCough suppressantCough suppressant and topical analgesic

Uses

  • On chest and throat, temporarily relieves cough due to common coldon muscles and joints temporarily relieves minor aches and painsWhen 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 ifmuscle 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 headaches. These could be a serious condition.If pregnant or breast feeding , ask a health professional before use.

Warningsfor External Use Only; Avoid Contact With Eyes

  • Do not useby mouthwith tight bandagesin nostrilson wounds or danages skinAsk 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

Directionssee Important Warning Under "When Using This Product."

  • Adults and children 2 years and over:rub a thick layer on chest and throat or rub on sore aching muscles.cover with a 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: do not use.Other informationStore at controlled room temperature 20°-25°C(68°-77°F)Questions1-800-222-1087

Inactive Ingredients

Carbomer, Cedarleaf oil, Cetyl Alcohol, Cetyl Palmitate, Cyclomethicone, Dimethicone, Disodium EDTA, Glycerin, Imidazolldnyl Urea, Isopropyl Palmitiate, Methylparaben , Nutmeg oil, PEG-100 Sterate, PEG/PPG- 18/18 Dimethicone, Propylparaben, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Thymol, Titantium Dioxide, Purfied Water

* Please review the disclaimer below.