Orajel Instant Pain Reliver for Canker Sores description, usages, side effects, indications, overdosage, supplying and lots more!

Orajel Instant Pain Reliver for Canker Sores

Church & Dwight Co., 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 Ingredients

Benzocaine 15%

Menthol 2%

Purpose

Oral pain reliever

Use

Use for the temporary relief of pain associated with minor irritation or injury of the mouth and gums; canker sores

Warnings

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

Flammable: keep away from fire or flame. Avoid smoking during the application and until product has dried.

Do not use more than directed; for more than 7 days unless directed by a dentist or doctor

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • swelling, reash or fever develops
  • irritaion, pain or redness persists or worsens

Keep out of reach of children.  In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Directions

  • cut open tip of tube on score mark
  • do not use if tube tip is cut prior to opening
  • do not peel off protective film
  • use up to 4 times daily or as directed by a dentist or doctor

Adults and children 2 years of age and over                   Dry affected area. Apply with cotton swab or finger.  Allow gel to dry for 30-60 seconds into a protective film.

Children under 12 years of age                                      Should be supervised in the use of this product

Children under 2 year of age                                         Ask a dentist or doctor

Inactive ingredients acesulfame potassium, alcohol (76.4% by volume), ethylcellulose, flavor, polycarbophil, water

Questions or comments? callus at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com.

Principal Display Panel

Principal Display Panel

Orajel Instant Pain Reliver for Canker Sores

Benzocaine, Menthol GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-707
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 150 mg
MENTHOL 20 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME
ALCOHOL
ETHYLCELLULOSES
polycarbophil
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 9.4 in 1 TUBE
2 NDC:10237-707-33 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-07-29


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