NDC 41250-706 Oral Analgesic Maximum Strength

NDC Product Code 41250-706

NDC 41250-706-21

Package Description: 1 TUBE in 1 CARTON > 6 g in 1 TUBE

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

NDC Product Information

Oral Analgesic Maximum Strength with NDC 41250-706 is a product labeled by Meijer Distribution Inc.. The generic name of Oral Analgesic Maximum Strength is . The product's dosage form is and is administered via form.

Labeler Name: Meijer Distribution Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

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.

  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • GELATIN (UNII: 2G86QN327L)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • PECTIN (UNII: 89NA02M4RX)
  • MINERAL OIL (UNII: T5L8T28FGP)

Product Labeler Information

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

Labeler Name: Meijer Distribution Inc.
Labeler Code: 41250
Start Marketing Date: 05-13-2010 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: 12-31-2018 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Oral Analgesic Maximum Strength Product Label Images

Oral Analgesic Maximum Strength 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 Ingredients          PurposeBenzocaine20%                  Oral pain relieverMenthol 0.25%                    Oral pain reliever

Otc - Purpose

Use     for the temporary relief of pain due to:canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

Allergy Alertdo not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzcaine or other "caine" anestheticsWhen using this productdo not use more than directeddo not use for more than 7 days unless directed by a doctor/dentistdo not use more than 4 times in a 24 hour period unless directed by a doctor/dentistStop use and ask a doctor ifsore mouth symptoms do not improve in 7 daysirritation, pain or redness persists or worsensswelling, rash or fever developsKeep out of reach of childrenin case of overdose, get medical help or contact a Poison Control Center right away

Directions

Directions    remove cap and cut tip of the tube on score markadults and children 2 years of age and over:  apply to tyhe affected area up to 4 times daily or as directed by doctor/dentistchildren under 12 years of age: should be supervised in the use of this productChildren under 2 years of age:  ask a doctor/dentistOther informationDo not use if tube tip is cut prior to opening.Inactive ingredients cellulose gum, gelatin, methyl salicylate, pectin, plasticized hydrdocarbon gel, polyethylene glycol, sodium saccharin

Otc - Questions

Questions or comments?  call us at 1-800-952-5080 M-F 9am-5pm

* Please review the disclaimer below.