Oral B Instant Pain Relief description, usages, side effects, indications, overdosage, supplying and lots more!

Oral B Instant Pain Relief

Health-Tech, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

  • 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

MM27Oral B Pain gel label

Oral B pain gel blister

MM28Oral B pain gel blister

Oral B shipper label

MM29Oral B shipper label

Oral B Instant Pain Relief

benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48871-008
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 0.2 mL

Inactive Ingredients

Ingredient Name Strength
BENZYL ALCOHOL
GLYCERIN
METHYLPARABEN
polyethylene glycol
polyethylene glycol 400
POLYETHYLENE GLYCOL 600
saccharin sodium
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

Product Characteristics

Color
green (FD and C Green 5)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 TUBE
2 3 in 1 BLISTER PACK
3 6 in 1 CARTON
4 NDC:48871-008-01 12 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part333 2010-07-01


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Be sure to consult your doctor before taking any medication!
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