NDC 10210-0026 Carmex Moisturising Lip Balm

Camphor (synthetic), Petrolatum

NDC Product Code 10210-0026

NDC 10210-0026-1

Package Description: 1 JAR in 1 BLISTER PACK > 7.5 g in 1 JAR

NDC 10210-0026-2

Package Description: 1 TUBE in 1 BLISTER PACK > 10 g in 1 TUBE

NDC Product Information

Carmex Moisturising Lip Balm with NDC 10210-0026 is a a human over the counter drug product labeled by Carma Laboratories, Inc.. The generic name of Carmex Moisturising Lip Balm is camphor (synthetic), petrolatum. The product's dosage form is salve and is administered via topical form.

Labeler Name: Carma Laboratories, Inc.

Dosage Form: Salve - A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster).

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.

Carmex Moisturising Lip Balm 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) 17 mg/g
  • PETROLATUM 461.6 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.

  • PARAFFIN (UNII: I9O0E3H2ZE)
  • LANOLIN (UNII: 7EV65EAW6H)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • MENTHOL (UNII: L7T10EIP3A)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • VANILLIN (UNII: CHI530446X)

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.
  • 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: Carma Laboratories, Inc.
Labeler Code: 10210
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: 06-01-2020 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 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.

Carmex Moisturising Lip Balm Product Label Images

Carmex Moisturising Lip Balm 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 1.70%White Petrolatum 46.16%

Purpose

External AnalgesicLip Protectant

Uses

  • Helps provide relief of symptoms of cold sores and dry lips

Warnings

For external use only

When Using This Product:

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If:

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days

Do Not Use On:

  • Deep puncture woundsserious burnsanimal bites

Keep Out Of Reach Of Children.

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

Directions

  • Apply to lips not more than 3 to 4 times dailychildren under 2 years of age: ask a doctor

Other Information

  • This is a personal care item, and should be used by one individual onlyprotect this product from excessive heat and direct sun

Inactive Ingredients

Petrolatum, lanolin, cera alba, cetyl esters, paraffin, theobroma cacao seed butter, camphor, menthol, salicylic acid, aroma, vanillin

* Please review the disclaimer below.