NDC 48871-008 Oral B Instant Pain Relief

NDC Product Code 48871-008

NDC CODE: 48871-008

Proprietary Name: Oral B Instant Pain Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
GREEN (C48329 - FD AND C GREEN 5)
Flavor(s):
MINT (C73404 - SCOPE ORIGINAL MINT FLAVOR)

NDC Code Structure

  • 48871 - Health-tech, Inc.

NDC 48871-008-01

Package Description: 12 CARTON in 1 BOX > 6 BLISTER PACK in 1 CARTON > 3 TUBE in 1 BLISTER PACK > 6 mL 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 B Instant Pain Relief with NDC 48871-008 is a product labeled by Health-tech, Inc.. The generic name of Oral B Instant Pain Relief is . The product's dosage form is and is administered via form.

Labeler Name: Health-tech, Inc.

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: K61870Z308)

Product Labeler Information

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

Labeler Name: Health-tech, Inc.
Labeler Code: 48871
Start Marketing Date: 01-01-1970 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.

Oral B Instant 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

Active Ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Uses

  • Temporarily relieves pain associated with the following mouth and gum irritations:toothachesore gumscanker soresbracesminor dental proceduresdentures

Warnings

Allergy Alert: do not use this pr9oduct if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other :caine" anesthetics.

When Using This Product

  • Avoid contact with eyesDo not exceed recommended dosageDo not use for more than 7 days unless directed by a doctor/dentist

Stop Use And Ask A Doctor If:

  • Sore mouth symptoms do not improve in 7 daysIrritation, pain or redness persist or worsensSwelling, pain or fever develops

Directions:

  • Remove cap-, squeeze gel onto applicatorAdults and children 2 years of age and older, apply to the affected area 4 times per day or as directed by a doctor/dentistChildren under 2 years of age; consult a doctor/dentistFor Denture wearersRemove DenturesApply thin layer to affected areaDo not reinsert dental work until irritation is relievedRinse mouth well before reinserting dentures

Other Information:

  • Store between 200 to 250 C (680 to 770 F) Do not refrigerateDo not purcahse if package has been opened

Inactive Ingredients

Benzyl alcohol, carbomer 974P, FD and C green 5, Flavor, glycerin, Methylparaben, Polyethylene glycol, PEG 400, PEG 600, Sodium Saccharin

Oral B Pain Gel Label

MM27

Oral B Pain Gel Blister

MM28

Oral B Shipper Label

MM29

* Please review the disclaimer below.