Active Ingredient
Benzocaine 20.0% ...................................................................... Oral anesthetic / analgesic
Rite Aid Liquid
FDA Label NDC 11822-5340
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Rite Aid (NDC 11822-5340). 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, package label.principal display panel, 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, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums
Warnings
For oral use only
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 Do not use for more than 7 days unless told to do so by a dentist or doctor If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or, if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.
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
to assure formation of long lasting film coating, dry affected area and apply
medication undiluted with applicator. allow a few seconds for coating to form. use up to 4 times
daily, or as directed by a dentist or doctor. children 12 years of age should be supervised in
the use of this product. children under 2 years of age:ask a dentist or doctor
Other Information
do not purchase if package has been opened
store at 20 - 25 C (68-77F)
close cap tightly after use to avoid evaporation
avoid contact with eyes
avoid contact with clothing and household furniture surfaces to avoid possible staining
this is a personal care item, and should be used by one individual only
Inactive Ingredients
Benzyl Alcohol, Cetylpyridinium
Chloride, Compound Benzoin Tincture,
Dimethyl Isosorbide, Ethylcellulose,
Flavor, Octylacrylamideacrylates/
butylaminoethyl/methacrylate
Copolymer, Oleth-10, PEG-6, Propylene
Glycol, Ricinus Communis (Castor)
Seed Oil, SD Alcohol 38B, Sucralose,
Tannic Acid.
Package Label.Principal Display Panel
Bottle
Blister
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