Drug Facts
Orajel 2x Medicated Toothache and Mouth Sores
Orajel Medicated For Toothache And Gum, Liquid
FDA Label NDC 10237-796
13 label sections · Submitted to the FDA by Church & Dwight Co., Inc. · 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 Medicated For Toothache And Gum, Liquid (NDC 10237-796). 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 drug facts, active ingredients, purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzocaine 20%
Menthol 0.1%
Purpose
Oral pain reliever
Uses
Usesfor the temporary relief of pain due to • canker sores • minor injury of the mouth and gums • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
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 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 or 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
Flammable: keep away from fire or flame. Avoid smoking during application.
Otc - Do Not Use
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
Otc - Stop Use
Stop use and ask a doctor if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than is used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
•remove safety seal from bottle cap
| adults and children 2 years of age and over | Apply product with applicator brush to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. |
| children between 2 and 12 years of age | should be supervised in the use of this product |
| children under 2 years of age | do not use |
Other Information
• do not use if safety seal on bottle cap is broken or missing prior to opening
Inactive Ingredients
alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccarin, water, yellow 5
Questions Or Comments?
Call us at 800 952 5080 M-F 9am-5pm ET or visit our website at www orajel.com
Package Label.Principal Display Panel
#1 ORAL PAIN
RELIEF BRAND
FOR TOOTHACHE AND MOUTH SORES
Orajel™
2x MEDICATED TOOTHACHE & MOUTH SORES
IMMEDIATE PAIN RELIEF
Relieves Throbbing Pain
Delivers Targeted Pain Relief
Provides Long-Lasting Pain Relief*
Soothes Irritated Gums
ORAL-PAIN
RELIEVER
NEW!
APPLICATOR
BRUSH
FAST-ACTING LIQUID
*Up to 2 Hours
0.45 FL OZ (13.3 mL)
* Please review the disclaimer below.
