Active Ingredient
Benzocaine 20%
Menthol 0.26%
Orajel 2x Medicated Gel
FDA Label NDC 10237-782
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 2x Medicated Gel (NDC 10237-782). 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 ingredient, purpose, use, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral pain reliever
Use
for the temporary relief of pain due to toothaches
Warnings
Methemogloblnemla 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, butacalne, benzocaine or other "caine" anesthetics
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 ■ symptoms do not improve in 7 days ■ swelling, rash
or fever develops ■ irrnation, pain or redness persists or worsens
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
- cut open tip of tube on score mark
Adults and children 2 years of age and over: apply to affected area up to 4 times daily or as directed by a dentist or doctor
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
■ do not use if tube tip is cut prior to opening ■ this preparation is intended for use in cases of toothache, only as temporary expedient
until a physician can be consulted
Inactive Ingredients
ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
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
#1 ORAL PAIN RELIEF BRAND FOR ADULTS
ORAJEL TM
2X TOOTHACHE & GUM MEDICATED
IMMEDIATE PAIN RELIEF
ORAL PAIN RELIEVER
- Soothes Irritated Gums
- Delivers Targeted Pain Relief
GEL
NET WT 0.25 OZ (7.0 g)
* Please review the disclaimer below.
