Active Ingredients
Benzocaine 20%
Menthol 0.1%
Zinc Chloride 0.15%
Orajel 3x Medicated For All Mouth Sores Gel
FDA Label NDC 10237-783
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Orajel 3x Medicated For All Mouth Sores (NDC 10237-783). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, warnings, do not use, stop use and ask a doctor if, keep out of reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral pain reliever and Oral astringent
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 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
- more than directed
- for more than 7 days unless directed by a dentist or doctor
- for teething
- in children under 2 years of age
Stop Use And Ask A Doctor If
- symptoms do not improve in 7 days
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
Keep Out Of Reach Of Children
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away
Other Information
do not use if Tamper-Evident Tab is open before first use
Inactive Ingredients
allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water
Questions Or Comments?
call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com
Principal Display Panel
#1 ORAL PAIN RELIEVER FOR TOOTHACHES
Ready-Open Tube Tip
Orajel
3X MEDICATED FOR ALL MOUTH SORES GEL
INSTANT PAIN RELIEF
Canker and Cold Sores Gum Irritation Cheek Bites Irritation from Dentures or Braces
20% Benzocaine to Relieve Oral Pain
Menthol to Soothe Gums
Astringent to Help Protect Sores from Irritation
ORAL PAIN RELIEVER/ASTRINGENT
NET WT
.18 OZ (5.1 g)
* Please review the disclaimer below.
