FDA Label for Orajel Medicated For Toothache And Gum, Liquid
View Indications, Usage & Precautions
Orajel Medicated For Toothache And Gum, Liquid 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.
Otc - Active Ingredient
Benzocaine 20%
Menthol 0.1%
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)
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