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

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Orajel Instant Pain Reliver for Canker Sores

Church & Dwight Co., Inc.

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.

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Orajel Instant Pain Reliver for Canker Sores

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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Be sure to consult your doctor before taking any medication!
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