FDA Label for Walgreens Maximum Strength
View Indications, Usage & Precautions
Walgreens Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. 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.
Active Ingredient
Benzocaine 20.0% ...................................................................... Oral pain reliever
Use
for the temporary relief of pain due to: • canker sores • cold sores • fever blisters • minor irritation of the mouth and gums
caused by dentures or orthodontic appliances
Warnings
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.
When using this product
• avoid contact with eyes • do not use more than directed • do not use for more than 7 days unless told to do
so 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, get medical help or contact a Poison Control Center right away.
Directions
• cut open tip of tube on score mark •
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 under 12 years of age should be supervised in the use of this product •
children under 2 years of age
: ask a dentist or doctor • for denture irritation apply a thin layer to the affected area; do not reinsert
dental work until irritation/pain is relieved; rinse mouth well after reinserting
Other Information
Do not use if tip is cut prior to opening. This preparation is intended for use in cases of toothache, only as a
temporary expedient until a dentist can be consulted. Do not use continuously.
Inactive Ingredients
Cellulose Gum, Gelatin, Menthol, Methyl Salicylate, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin.
Dosage & Administration
• use up to 4 times daily, or as directed by a dentist or doctor • children under 12 years of age should be supervised in
the use of this product • children under 2 years of age: consult a dentist or doctor
Package Label.Principal Display Panel
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