Orajel Severe Toothache description, usages, side effects, indications, overdosage, supplying and lots more!

Orajel Severe Toothache

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 ingredient

Active ingredient

Benzocaine 20%

Purpose

Purpose

Oral pain reliever

Uses

Use for the temporary relief of pain due to toothaches

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 application and until product has dried
                                                                                                                                                                              

Do not use

  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor                   
                                                                                                                                                                                    

Stop use and ask a doctor if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
                                                                                                                                                                                

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

  • remove imprinted safety seal from bottle cap
adults and children 2 years and older



Apply product with cotton swab or finger to the cavity and around gum surrounding the teeth.  Use up to 4 times daily or as directed by a dentist or doctor




Children under 12 years of age



Should be supervised in the use of this product



Children under 2 years of age



Ask a dentist or doctor




Other information

  • do not use if imprinted bottle seal is broken or missing prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
  • do not use continuously

Inactive ingredients  alcohol (54.6% by volume), flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5

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

Principal Display Panel


#1 ORAL PAIN RELIEVER
     FOR TOOTHACHE


Orajel                     liquid
Instant Pain Relief


SEVERE TOOTHACHE

MAXIMUM STRENGTH
FAST-ACTING FORMULA



Carton imagePrincipal Display Panel

Orajel Severe Toothache

Benzocaine LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-722
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 0.2 mL

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
polyethylene glycol 400
saccharin sodium
water
FD&C RED NO. 40
FD&C YELLOW NO. 5

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 13.3 in 1 BOTTLE, GLASS
2 NDC:10237-722-45 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-03-21


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Be sure to consult your doctor before taking any medication!
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