NDC 10237-756 Orajel For Cold Sores Single Dose

Benzalkonium Chloride, Benzocaine

NDC Product Code 10237-756

NDC 10237-756-04

Package Description: 2 VIAL, SINGLE-DOSE in 1 PACKAGE > .02 g in 1 VIAL, SINGLE-DOSE

NDC Product Information

Orajel For Cold Sores Single Dose with NDC 10237-756 is a a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Orajel For Cold Sores Single Dose is benzalkonium chloride, benzocaine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Church & Dwight Co., Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 Single Dose 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.

  • BENZALKONIUM CHLORIDE .13 mg/g
  • BENZOCAINE .5 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.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • WATER (UNII: 059QF0KO0R)

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: 07-01-2012 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.

Orajel For Cold Sores Single Dose Product Label Images

Orajel For Cold Sores Single Dose 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

ACTIVE INGREDIENTSBenzalkonium chloride, 0.13%


Benzocaine, 5%

Otc - Purpose

PURPOSETopical Antiseptic


Pain Reliever

Indications & Usage

  • USESto treat cold sores / fever blisters

Warnings

WARNINGSFor external use only. Flammable, keep away from fire or flame. 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

  • In the eyesover large areas of the bodyif you are allergic to any ingredient in this productmore than 3 times per daylonger than one week unless directed by a physician

Stop Use And Ask A Dentist Or Physician If

  • Condition persists or worsenssymptoms persist for more than 7 days

Ask A Physician If

  • Used to treat deep or puncture wounds, animal bites, or serious burnsyou are pregnant or nursing a baby

When Using This Product

You may feel a brief stinging sensation when you apply it.  The sting should go away in a short time.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDRENIn case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DIRECTIONSAdults and children over 2 years of age:
  • Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using only warm water or alcoholSlide off to remove the protective blue paper cover and slide it on the other end-opposite the white applicator tipSqueeze the vial firmly on the arrow shown on the blue paper cap until you hear it snapHold with the white applicator tip down to allow the medication to saturate the tipTo minimize pain during application gently touch the site of the cold sore with the saturated applicator tip. Once the area is numb, rub the site of the cold sore and the surrounding area.  Rub firmly to allow the treatment to deeply penetrate the skin.To treat most cold sores, usually one treatment is enough.  If your symptoms go away and then return later, apply another dose for the second cold soreDo not use more than 3 times per dayDiscard after use.Children under 2 years of age: ask a dentist or physician.
  • OTHER INFORMATIONStore at room temperatureThe ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in Orajel Single Dose.For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for one hour after applying the drug.

Inactive Ingredient

INACTIVE INGREDIENTSisopropyl alcohol (70% v/v), water

Otc - Questions

Questions or coments? call us at


1-800-952-5080 M-F ET or visit our website at


www.orajel.com

* Please review the disclaimer below.