NDC 10237-789 Orajel 4x Medicated Pm For Toothache And Gum

Benzalkonium Chloride, Benzocaine, Menthol, Zinc Chloride

NDC Product Information

Orajel 4x Medicated Pm For Toothache And Gum with NDC 10237-789 is a a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Orajel 4x Medicated Pm For Toothache And Gum is benzalkonium chloride, benzocaine, menthol, zinc chloride. 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 4x Medicated Pm For Toothache And Gum 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
  • BENZALKONIUM CHLORIDE 1.3 mg/g
  • ZINC CHLORIDE 1.5 mg/g
  • MENTHOL 2.6 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.

  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • GLYCYRRHIZIN (UNII: 6FO62043WK)
  • CHAMOMILE (UNII: FGL3685T2X)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SORBIC ACID (UNII: X045WJ989B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
  • SACCHARIN (UNII: FST467XS7D)

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: Church & Dwight Co., Inc.
Labeler Code: 10237
FDA Application Number: part333A 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: 11-01-2019 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: 12-31-2020 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 4x Medicated Pm For Toothache And Gum Product Label Images

Orajel 4x Medicated Pm For Toothache And Gum 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 0.14%Benzocaine 20%Menthol 0.26%Zinc chloride 0.15%

Purpose

Oral antiseptic, Oral pain reliever, Oral astringent

Uses

  • For the temporary relief of pain due to minor irritation or injury of the mouth and gumsfirst aid to help prevent infection in minor oral irritation

Warnings

Methemoglobinemia 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

Do Not Use

  • More than directedfor more than 7 days unless directed by a dentist or doctorfor teethingin children under 2 years of age

Stop Use And Ask A Doctor If

  • Symptoms do not improve in 7 daysswelling, rash or fever developsirritation, pain or redness persists or worsens

Keep Out Of Reach Of Children

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

Directions

  • Adults and children 2 years of age and olderApply to affected area up to 4 times daily or as directed by a dentist or doctorChildren between 2 and 12 years of ageAsk a doctor before use. Should be supervised in the use of this productChildren under 2 years of ageDo not use

Other Information

  • Do not use if Tamper-Evident Tab is open before first useavoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive Ingredients

Ammonium glycyrrhizate, chamomile, flavor, PEG-8, PEG-75, PEG/PPG 116/66 copolymer, poloxamer 407, sodium saccharin, sorbic acid, titanium dioxide, water

* Please review the disclaimer below.