FDA Label for Orajel 3x Medicated For Denture Pain
View Indications, Usage & Precautions
Orajel 3x Medicated For Denture Pain 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 0.5%
Zinc Chloride 0.15%
Otc - Purpose
Benzocaine - Oral Pain Reliever
Menthol - Oral Pain Reliever
Zinc Chloride - Oral Astringent
Indications & Usage
Use for the temporary relief of • pain due to minor irritation of the mouth and gums caused by dentures • occasional minor irritation, pain, sore mouth
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 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 heartrate • 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
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 • irritation, 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
Dosage & Administration
Directions
Adults and children 2 years of age and over | Apply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. 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 Safety Information
do not use if Tamper-Evident Tab is open before first use
Inactive Ingredient
ammonium glycyrrhizate, benzalkonium chloride, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water
Otc - Questions
Questions? call us at 800-952-5080 M-F 9am - 5pm or visit www.orajel.com
Package Label.Principal Display Panel
#1
ORAL PAIN
RELIEVER BRAND
FOR ADULTS
Ready-Open Tube Tip
Orajel™
3X MEDICATED
FOR DENTURE PAIN
INSTANT PAIN RELIEF
GEL
20% Benzocaine to Relieve Pain from Dentures
Astringent to Relieve Gum Irritation
Menthol to Soothe Gums Irritated by Dentures
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