1. Home
  2. Labeler Index
  3. Health-tech, Inc.
  4. 48871-008
  5. Label Information: Oral B Instant Pain Relief

FDA Label for Oral B Instant Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF:
    7. DIRECTIONS:
    8. OTHER INFORMATION:
    9. INACTIVE INGREDIENTS
    10. ORAL B PAIN GEL LABEL
    11. ORAL B PAIN GEL BLISTER
    12. ORAL B SHIPPER LABEL

Oral B Instant Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Health-tech, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.