Oral B Instant Pain Relief
FDA Label NDC 48871-008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Health-tech, Inc. for the product Oral B Instant Pain Relief (NDC 48871-008). 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, purpose, uses, warnings, when using this product, stop use and ask a doctor if:, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Uses

Temporarily relieves pain associated with the following mouth and gum irritations:

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
  • dentures

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 eyes
  • Do not exceed recommended dosage
  • Do 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 days
  • Irritation, pain or redness persist or worsens
  • Swelling, pain or fever develops

Directions:

  • Remove cap-, squeeze gel onto applicator
  • Adults and children 2 years of age and older, apply to the affected area 4 times per day or as directed by a doctor/dentist
  • Children under 2 years of age; consult a doctor/dentist
    • For Denture wearers
    • Remove Dentures
    • Apply thin layer to affected area
    • Do not reinsert dental work until irritation is relieved
    • Rinse mouth well before reinserting dentures

Other Information:

  • Store between 200 to 250 C (680 to 770 F) Do not refrigerate
  • Do 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 Tooth Pain Gel Label (Oralblabel)

Oral B Tooth Pain Gel Label (Oralblabel)

Oral B Pain Gel Blister

MM28

Oral B Tooth Pain Gel Blister (Oralbblister)

Oral B Tooth Pain Gel Blister (Oralbblister)

Oral B Shipper Label

MM29

Oral B Shipper Label (Oralbshipperlabel)

Oral B Shipper Label (Oralbshipperlabel)

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