FDA Label for Orajel 2x Medicated Gel
View Indications, Usage & Precautions
Orajel 2x Medicated Gel 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.
Active Ingredient
Benzocaine 20%
Menthol 0.26%
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.
