Active Ingredient
Benzocaine 20.0% ...................................................................... Oral pain reliever
Walgreens Paste, Dentifrice
FDA Label NDC 0363-5337
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens (NDC 0363-5337). 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 active ingredient, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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