FDA Label for Orajel Cold Sore Touch Free - Single Dose
View Indications, Usage & Precautions
Orajel Cold Sore Touch Free - Single Dose Product Label
The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Benzalkonium chloride
Benzocaine
Purpose
Benzalkonium chloride 0.13% ...................................................Topical Antiseptic
Benzocaine 5% .........................................................................Topical Anesthetic
Uses
to treat cold sores/fever blisters
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
Otc - Do Not Use
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
Otc - Stop Use
Stop use and ask a dentist or physician if •condition persists or worsens •symptoms persist for more than 7 days
Otc - Ask Doctor
Ask a physician if •used to treat deep or puncture wounds, animal bites or serious burns •you are pregnant or nursing a baby
Otc - When Using
When using this product you may feel a brief stinging 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 children. In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away
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 |
Other Information
•store at room temperature • the ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in this product •for best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for at least one hour after applying the drug •do not use if package is torn, cut or otherwise damaged
Inactive Ingredients
isopropyl alcohol (70% v/v), water
Questions Or Comments?
call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com
Package Label.Principal Display Panel
NEW
LOOK
#1 ORAL PAIN
RELIEF BRAND
FOR ADULTS
BONUS
50% MORE
Orajel™
COLD SORE
PROVIDES IMMEDIATE, TARGETED PAIN RELIEF
LIQUID
FORMULA
TOPICAL ANTISEPTIC
TOPICAL ANESTHETIC
CONTAINS 6 TREATMENT VIALS
NET 0.12 FL OZ (3.5 mL) TOTAL
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