NDC 41250-407 Meijer Cold Sore Treatment

Camphor

NDC Product Code 41250-407

NDC 41250-407-01

Package Description: 1 TUBE in 1 PACKAGE > 2 g in 1 TUBE

NDC Product Information

Meijer Cold Sore Treatment with NDC 41250-407 is a a human over the counter drug product labeled by Meijer Distribution Inc. The generic name of Meijer Cold Sore Treatment is camphor. 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: 1374851.

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.

Meijer Cold Sore Treatment 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARGININE (UNII: 94ZLA3W45F)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • CERESIN (UNII: Q1LS2UJO3A)
  • CETEARYL ISONONANOATE (UNII: P5O01U99NI)
  • CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)
  • DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • HEXYLDECANOL (UNII: 151Z7P1317)
  • HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • THYMOL (UNII: 3J50XA376E)
  • TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)
  • ZINC CHLORIDE (UNII: 86Q357L16B)

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: Meijer Distribution Inc
Labeler Code: 41250
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: 04-05-2013 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: 12-31-2022 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".

* Please review the disclaimer below.

Meijer Cold Sore Treatment Product Label Images

Meijer Cold Sore Treatment 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

Benzalkonium chloride 0.13%Camphor 3.0%

Purpose

Cold sore/fever blister treatment/first aid antiseptic

Uses

  • •for treatment of cold sores/fever blisters on the face or lips •temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters •first aid to help protect against infection in minor cuts, scrapes, burns, and sores

Warnings

  • For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician. Allergy Alert: Do not use if you are allergic to any of the ingredients in this product. When using this product avoid contact with eyes. Use only as directed.Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor

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 at 1-800-222-1222.

Directions

  • •clean the affected area •apply a small amount of this product to the affected area 1 to 3 times daily •rub in gently •may be covered with a sterile bandage •wash hands before and after applying cream •do not share this product with anyone •children under 12 years of age: ask a doctor

Other Information

Store at room temperature

Inactive Ingredients

Alcohol, aloe barbadensis leaf juice, arginine, butylparaben, cetearyl isononanoate, dipropylene glycol dicaprylate/dicaprate, ethylparaben, eucalyptus globulus leaf oil, hexyl decyl laurate, hexyldecanole, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylparaben, thymol, tocopheryl nicotinate (vitamin e), zinc chloride

* Please review the disclaimer below.