NDC 10237-797 Orajel For Cold Sores Double Medicated, Cream

Benzocaine And White Petrolatum

NDC Product Code 10237-797

NDC CODE: 10237-797

Proprietary Name: Orajel For Cold Sores Double Medicated, 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: Benzocaine And White Petrolatum 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

  • 10237 - Church & Dwight Co., Inc.
    • 10237-797 - Orajel For Cold Sores Double Medicated, Cream

NDC 10237-797-12

Package Description: 1 TUBE in 1 CARTON > 3.5 g in 1 TUBE

NDC Product Information

Orajel For Cold Sores Double Medicated, Cream with NDC 10237-797 is a a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Orajel For Cold Sores Double Medicated, Cream is benzocaine and white petrolatum. The product's dosage form is cream and is administered via topical form.

Labeler Name: Church & Dwight Co., Inc.

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.

Orajel For Cold Sores Double Medicated, 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.

  • BENZOCAINE 200 mg/g
  • PETROLATUM 736.4 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.

  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • PRUNELLA VULGARIS (UNII: ID3IB81B1C)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • WATER (UNII: 059QF0KO0R)
  • CORN OIL (UNII: 8470G57WFM)

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: Church & Dwight Co., Inc.
Labeler Code: 10237
FDA Application Number: part356 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: 01-18-2021 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 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.

Orajel For Cold Sores Double Medicated, Cream Product Label Images

Orajel For Cold Sores Double Medicated, 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

Otc - Active Ingredient

Benzocaine 20%White petrolatum 73.64%

Otc - Questions

Questions or comments? call us at
1-800-952-5080 M-F 9am-5pm or visit our website at
www.orajel.com

Otc - Purpose

Topical anestheticSkin protectant

Indications & Usage

Use temporarily relieves pain, itching and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

Warnings

WarningsFor external use onlyMethemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Otc - Do Not Use

  • Do not usemore than directedfor more than 7 days unless directed by a physician or healthcare providerfor teethingin children under 2 years of age

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionscut open tube of tip on score markDo not use if tip is cut prior to openingAdults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times dailyChildren betweem 2 and 12 years of age: Ask a doctor before use. Should be supervised in the use of this productChildren under 2 years of age: Do not use

Inactive Ingredient

Inactive ingredients cholecalciferol, mineral oil, phenoxyethanol (and) hydroxyacetophenone (and) caprylyl glycol (and) water, propylene glycol, prunella vulgaris leaf extract, retinyl palmitate (vitamin A palmitate), tocopherol, tocopherol acetate (vitamin E acetate), zea mays (corn) oil

* Please review the disclaimer below.