Otc - Active Ingredient
Benzocaine 20%
Menthol 0.1%
Orajel Medicated For Toothache And Gum, Liquid
FDA Label NDC 10237-796
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 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral Pain Reliever
Indications & Usage
Use for 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 cuse methemoglobinemia, a serious condition that must be treated promptly becasue 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 physician if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days
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
Dosage & Administration
Directions • remove imprinted safety seal from bottle cap
Adults and children 2 years of age and over
- Apply product with cotton swab or finger to the affected area. Use up to 4 times daily or as directed by a dentist or doctor
- Ask a doctor before use. Should be supervised in the use of this product
- Do not use
Children under 12 years of age
Children under 2 years of age
Other Safety Information
Other Information • do not use if safety seal on bottle cap is broken or missing prior to opening
Inactive Ingredient
Inactive Ingredients alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccarin, water, yellow 5
Otc - Questions
Questions or comment? Call us at 800 952 5080 M-F 9am-5pm or visit our website at www orajel.com
Package Label.Principal Display Panel
#1
ORAL PAIN
RELIEVER BRAND
FOR TOOTHACHE
Fast-Acting Liquid!
Orajel
MEDICATED
FOR TOOTHACHE & GUM
Instant Pain Relief
•20% Benzocaine to Relieve Oral Pain
•Menthol to Soothe Gums
CANKER SORES • CHEEK BITES • DENTURE PAIN
IRRITATION FROM BRACES
ORAL PAIN RELIEVER
0.45 FL OZ (13.3mL)
Ojfc-32945-07 (Ojfc 32945 07)
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