Active Ingredients
Benzocaine 20%
Menthol 0.26%
Zinc chloride 0.15%
Orajel Rescue Relief Pen Gel
FDA Label NDC 10237-731
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 Rescue Relief Pen (NDC 10237-731). 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, uses, warnings, do not use, stop use and ask a dentist or doctor if, 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 / Oral Astringent
Uses
• for the temporary relief of
• pain due to minor irritation or injury of the mouth and gums
• occasional sore mouth and sore throat
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 Dentist Or Doctor If
• sore throat is severe, persists for more than 2 days
• sore mouth symptoms do not improve in 7 days
• headache, nausea, vomiting, 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.
Directions
| adults and children 2 years of age and older | apply to the 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 package has been opened
Inactive Ingredients
ammonium glycrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water
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™
TOOTHACHE & GUM
IMMEDIATE RELIEF OF:
ORAL PAIN
BRACE/DENTURE IRRITATION
GUM DISCOMFORT
CANKER SORES
RESCUE RELIEF PEN
GENTLE. TARGETED. TOUCH-FREE.
PLUS COOLING RELIEF
50+ USES
ORAL PAIN RELIEVER / ASTRINGENT
NET WT 0.07 OZ (2.0 g)
* Please review the disclaimer below.
