Drugplain

Orajel Cold Sore Touch Free - Single Dose 1.3 mg/mL

Benzalkonium Chloride, Benzocaine · LIQUID · Church & Dwight Co., Inc.

No Recall History
Plain English

Orajel Cold Sore Touch Free - Single Dose is a prescription liquid containing benzalkonium chloride, benzocaine at 1.3 mg/mL, taken topical. Manufactured by Church & Dwight Co., Inc..

Key Facts

Brand Name
Orajel Cold Sore Touch Free - Single Dose
Generic Name
Benzalkonium Chloride, Benzocaine
NDC Code (Product)
10237-798
Manufacturer
Church & Dwight Co., Inc.
Strength
1.3 mg/mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
HUMAN OTC DRUG
Application #
M017
Drug Class
Allergens [CS]; Cell-mediated Immunity [PE]
Marketing Start
09/01/2021

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses to treat cold sores/fever blisters

Dosage & Administration

Directions •slide-off to remove the protective blue paper cover and slide it on the other end - opposite the white applicator tip •squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap •hold with the white applicator tip down to allow the medication to saturate the tip •to 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, multiple treatments may be required •discard after use •for best result ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick Adults and children 2 years of age and older Do not use more than 3 times per day Children between 2 and 12 years of age Ask a doctor before use. Should be supervised in the use of this product Children under 2 years of age Do not use

Warnings

Warnings For external use only. Flammable, keep away from fire or flame. 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 •in the eyes •over large areas of the body •if you are allergic to any ingredient in this product •more than 3 times per day •longer than 1 week unless directed by a physician •for teething •in children under 2 years of age Stop use and ask a dentist or physician if •condition persists or worsens •symptoms persist for more than 7 days Ask a physician if •used to treat deep or puncture wounds, animal bites or serious burns •you are pregnant or nursing a baby When using

Frequently Asked Questions

What is Orajel Cold Sore Touch Free - Single Dose used for?

Orajel Cold Sore Touch Free - Single Dose contains Benzalkonium Chloride, Benzocaine. It is a liquid taken topical. Consult your doctor for specific uses.

Is Orajel Cold Sore Touch Free - Single Dose a controlled substance?

Orajel Cold Sore Touch Free - Single Dose is not classified as a controlled substance by the DEA.

What is the generic name for Orajel Cold Sore Touch Free - Single Dose?

The generic name for Orajel Cold Sore Touch Free - Single Dose is Benzalkonium Chloride, Benzocaine. There are 7 other brand versions of Benzalkonium Chloride, Benzocaine.

What is the NDC code for Orajel Cold Sore Touch Free - Single Dose 1.3 mg/mL?

The NDC (National Drug Code) for Orajel Cold Sore Touch Free - Single Dose 1.3 mg/mL is 10237-798, listed by Church & Dwight Co., Inc..