NDC 41520-097 Careone Cold Sore Treatment

Camphor, Menthol, Phenol, White Petrolatum

NDC Product Code 41520-097

NDC 41520-097-01

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

NDC Product Information

Careone Cold Sore Treatment with NDC 41520-097 is a a human over the counter drug product labeled by American Sales Company. The generic name of Careone Cold Sore Treatment is camphor, menthol, phenol, white petrolatum. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2175793.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Careone 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.

  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: American Sales Company
Labeler Code: 41520
FDA Application Number: part333E 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: 03-11-2020 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 - 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.

Careone Cold Sore Treatment Product Label Images

Careone 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

Camphor 3.00%Menthol 1.00%Phenol 1.50%White Petrolatum 89.20%


Cold sore/fever blister treatmentSkin Protectant


  • •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 •Temporarily protects minor cuts, scrapes, burns, and sores •Helps prevent and temporarily protects chapped or cracked skin and lips


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.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


  • •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

Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol, Tocopheryl Nicotinate

* Please review the disclaimer below.