Rite Aid Liquid Anesthetic Oral Pain Relief
FDA Label NDC 11822-3950

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 Corporation for the product Rite Aid Liquid Anesthetic Oral Pain Relief (NDC 11822-3950). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                 PurposeBenzocaine, 20%............................................Anesthetic

Otc - Purpose

Uses- temporary relieves pain associated with:      - canker sores- minor irritation or injury of mouth and gums  - minor dental procedures- minor irritation of mouth and gums caused by dentures or orthodontic appliancesalso for the temporary relief of sore gums due to teething in children 2 years of age and older

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If more than is used for oral anesthetic is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Uses- temporary relieves pain associated with:      - canker sores - minor irritation or injury of mouth and gums  - minor dental procedures - minor irritation of mouth and gums caused by dentures or orthodontic appliances also for the temporary relief of sore gums due to teething in children 2 years of age and older

Warnings

Warnings Fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, contact your doctor.Do not use - for more than directed - for more than 7 days, unless directed by a dentist or doctor-  if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anestheticsWhen using this product- avoid contact with the eyes - do not exceed recommended dosageStop 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 worsensKeep out of reach of children.If more then used for oral anesthetic is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions Adults and children 2 years of age and older- apply to the affected area  - allow to remain in place at least 1 minute and then spit out - use up to four times a day or as directed by a dentist or doctorFor teething apply to affected area not more than 4 times dialy, or as directed by a dentist or doctorChildren under 2 years of age consult a dentist or doctorChildren under 12 years of age should be supervised in the use of this product

Inactive Ingredient

Inactive IngredientsPEG-8, propylene glycol, flavor, benzyl alcohol, methylparaben, saccharin, red 40, yellow 10, blue 1

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