Mouth Sore Relief Liquid
FDA Label NDC 59779-830

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Mouth Sore Relief (NDC 59779-830). 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

Active Ingredient

Benzocaine 20.0% (w/w) ...................................................................... Oral anesthetic/analgesic

Use

For the temporary relief of pain due to canker sores, minor irritation of the mouth andgums 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 directed 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. If swallowed, get medical help or contact a Poison Control Center
right away.

Directions

• to assure formation of long-lasting film coating, dry affected area and applymedication undiluted with applicator • allow a few seconds for coating to form

Other Information

• do not use if package has been opened• store at 20-25˚C (68-77°F)• close cap tightly after use to avoid evaporation• avoid contact with eyes• avoid contact with clothing and household/furniture surfaces to prevent possible staining• this is a personal care item, and should be used by one individual only

Inactive Ingredients

Benzyl Alcohol, CetylpyridiniumChloride, Compound Benzoin Tincture,Dimethyl Isosorbide, Ethylcellulose,Flavor, Octylacrylamide/acrylates/butylaminoethyl/methacrylateCopolymer, Oleth-10, PEG-6, PropyleneGlycol, Ricinus Communis (Castor)Seed Oil , SD Alcohol 38B, Sucralose,Tannic Acid.

Package Label.Principal Display Panel

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 inthe use of this product • children under 2 years of age: consult a dentist or doctor

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