FDA Label for Orajel
View Indications, Usage & Precautions
Orajel Product Label
The following document was submitted to the FDA by the labeler of this product Biofilm. 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.
Otc - Active Ingredient
Benzocaine 15 mg
Menthol 2.5 mg
Otc - Purpose
Benzocaine - Oral Pain Reliever
Menthol - Oral Pain Reliever
Indications & Usage
Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums
Warnings
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 to the 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 • fatique 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 • more than directed • for more than 7 days unless directed by a physician or healthcare provider • for teething • in children under 12 years of age
Otc - Stop Use
Stop use and ask a phyisican if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs
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
Dosage & Administration
Directions • make sure hands are dry and free of moisture as strip may be sticky/tacky • tear open pouch and remove blue strip
Adults and children 12 years or age and over: Using either side of strip, immediately place directly onto the affected area keeping tongue and lips clear. Gently press for 5-10 seconds until strip adheres to the area. Strip will stay in place and dissolve slowly in mouth for up to 1 hour for duration of treatment. Use up to 4 times daily or as directed by a physician or healthcare provider.
Children under 12 years of age: Do not use
Other Safety Information
Other Information • do not use if pouch is torn or cut prior to opening • do not use continously • for best results, avoid drinking warm beverages or eating for at least one hour after applying the product
Inactive Ingredient
acid blue 9, glycerin, PEG-8, PEG-90, polycarbophil, potassium sorbate, pullulan, PVP, titanium dioxide, water.
Otc - Questions
Questions • call us at 800 952 5080 Monday through Friday 9am to 5pm or visit our website at www orajel com
Package Label.Principal Display Panel
#1 ORAL PAIN
Reliever Brand
For Toothache
NEW!
SLOW DISSOLVING STRIPS
For Lasting Relief
Orajel™
TOOTHACHE STRIPS
MEDICATED FOR TOOTHACHE & GUM
INSTANT & TARGETED PAIN RELIEF
• Long-Lasting Pain Relief
•Maximum level of Pain Relief with 15mg Benzocaine*
•Stays in place for Targeted Relief
•Soothes gums with Menthol
Cool Mint Taste
8 STRIPS
Individually Wrapped
Oral Pain Reliever
* Please review the disclaimer below.