FDA Label for Orajel Denture Pain Relief
View Indications, Usage & Precautions
Orajel Denture Pain Relief 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.
Otc - Active Ingredient
Benzalkonium Chloride 0.1%
Benzocaine 20%
Menthol 0.7%
Otc - Purpose
Benzalkonium Chloride - Oral antiseptic
Benzocaine - Oral pain reliever
Menthol - Oral pain reliever
Indications & Usage
Use for the temporary relief of • pain due to minor irritation of the mouth and gums caused by dentures • occasional minor irritation, pain, sore mouth.
Warnings
Warnings
• 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
Otc - Stop Use
Stop use and ask a physician 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
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
Directions
cut open tube on score mark
Adults and children 2 years of age and over:
Apply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. Use up to 4 times daily or as directed by a physician or healthcare provider.
Children under 12 years of age:
Should be supervised in the use of this product
Children under 2 years of age:
Ask a physician or healthcare provider
Other Information • do not sue if tube tip is cut prior to opening • this preparation is intended for use in cases of denture pain, only as a temporary expedent until a physician can be consulted • do not use continuously • Orajel Denture Pain Gel will stay in place for extended duration of relief
Inactive Ingredient
Inactive Ingredients blue 1, cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin, water
Otc - Questions
Questions or comments call us at 800 952 5080 Monday through Friday 9-5 or visit our website www orajel com
Package Label.Principal Display Panel
#1
Oral Pain
Reliever Brand
For Adults
New Formula!
3x More
Active Ingredients*
Orajel
Instant Pain Relief
For Denture Pain
Soothes Gum Pain & Irritation
Triple Medicated
10% Benzocaine to Relieve Pain from Dentures
Astringent to Relieve Gum Irriation NEW
Menthol to Soothe Gums Irritated by Dentures
Refreshing Mint
Long-Lasting Gel
Oral Pain Reliever/Astringent NET WT 0.25 OZ (7.0g)
* Please review the disclaimer below.
