FDA Label for Orajel Instant Pain Relief Maximum Strength
View Indications, Usage & Precautions
Orajel Instant Pain Relief Maximum Strength 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
Active Ingredients Benzalkonium chloride 0.02% Benzocaine 20% Zinc chloride 0.1%
Purpose
Purpose
Oral antiseptic
Oral pain reliever
Pral astringent
Indications & Usage
Use for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums. To help protect against infection in minor oral irritation.
Warnings
Allergy Alert
do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzcaine or other "caine" anesthetics
Do not use
more than is directed
for more than 7 days unless directed by a dentist or doctor
Stop use and ask a doctor if
sore mouth 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 cut open tip of tube on score mark, do not use if tube tip is cut prior to opening
Adults and children 2 years of age and over Apply to affected are up to 4 times daily or as directed by dentist or doctor.
Children under 12 years of age Should be supervised in the use of the product
Children under 2 years of age Ask a dentist or doctor
Inactive Ingredient
Inactive ingredients allantoin, carbomer, edetate disodiu, mentha piperota (peppermint) oil, polyethylene glycol, polysorbate 60, propylene glycol, propyl gallate, purified water, pvp, sodium saccharin, sorbic acid, stearyl alcohol
Principal Display - Carton
TRIPLE MEDICATED for FAST
EFFECTIVE RELIEF
Orajel gel
Instant Pain Relief
For all Mouth Sores
MAXIMUM STRENGTH
SAFETY SEALED TUBE TIP
NET WT 0.125 OZ (3.5g) ORAL PAIN RELIEVER / ORAL ANTISEPTIC / ORAL ASTRINGENT
carton image
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