Rite Aid
FDA Label NDC 11822-0317

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 11822-0317). 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, uses, 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

Benzalkonium Chloride 0.02% .................................................... Oral Antiseptic

Benzocaine 7.5% ...................................................................... Oral Pain Reliever

Zinc Chloride 0.1% ................................................................... Oral Astringent

Uses

temporarily relieves pain caused by canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

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

  • Do not use more than directed 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 get better 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. do not use if tip is cut prior to opening

Adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a doctor. Children under 12 years should be supervised in the use of this product.

Childern under 2 years of age: ask a dentist or doctor

Other Information

Do not use if tip is cut prior to opening.

Inactive Ingredients

Allantoin, Carbomer, Edetate Disodium, Mentha Piperota (Peppermint) Oil, Polyethylene Glycol, Polysorbate 60, Propylene Glycol, Propyl Gallate, Purified Water, PVP, Sodium Saccharin, Sorbic Acid, Stearyl Alcohol

Package Label.Principal Display Panel

mm1.jpg

Carton Label (Mm1)

Carton Label (Mm1)

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Tube Label (Mm2)

Tube Label (Mm2)

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