NDC 11822-3950 Rite Aid Liquid Anesthetic Oral Pain Relief

NDC Product Code 11822-3950

NDC 11822-3950-6

Package Description: 1 TUBE, WITH APPLICATOR in 1 CARTON > 30 mL in 1 TUBE, WITH APPLICATOR

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Rite Aid Liquid Anesthetic Oral Pain Relief with NDC 11822-3950 is a product labeled by Rite Aid Corporation. The generic name of Rite Aid Liquid Anesthetic Oral Pain Relief is . The product's dosage form is and is administered via form.

Labeler Name: Rite Aid Corporation

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SACCHARIN (UNII: FST467XS7D)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rite Aid Corporation
Labeler Code: 11822
Start Marketing Date: 07-08-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Rite Aid Liquid Anesthetic Oral Pain Relief Product Label Images

Rite Aid Liquid Anesthetic Oral Pain Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling 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

* Please review the disclaimer below.