Orajel Nighttime Instant Relief for Teething Pain description, usages, side effects, indications, overdosage, supplying and lots more!

Orajel Nighttime Instant Relief for Teething Pain

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 Ingredients

Benzocaine 10%

Purpose

Purpose
Oral pain reliever

Uses

USE
For the temporary relief of sore gums due to teething in children 2 years of age and older.  For use in children under the age of 2, consult a physician or healthcare provider.

Warnings

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

do not use
  • more that directed
  • for more than 7 days unless directed by a physician or healthcare provider
                                                                                                                                                                               
When using this product  
  • fever and nasal congestion are not symptoms of teething and may indicate the presence of infection.  If these symptoms persists, consult your physician.

                                                                                                                                                                              

Stop use and ask a doctor if      

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness does not go away
  • swelling, rash or fever develops

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

  • wash hands
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of Orajel and spread over the gums
  • apply to the affected area up to 4 times daily or as directed by a physician or healthcare provider
  • for children under 2 years of age, consult a physician or healthcare provider

Other information  

In active ingredients   cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin

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

Principal Display Panel

No. 1 TEETHING BRAND
        used by Pediatricians

                          Nighttime
                      Orajel
       

Instant Relief for Teething Pain                            cherry flavored gel

LONGER LASTING           EXTRA STRENGTH   for Nighttime

NET WT 0.18 OZ (5.1g) GEL            ORAL PAIN RELIEVER FOR TEETHING       BENZOCAINE 10%

Carton imagePrincipal Display Panel

Orajel Nighttime Instant Relief for Teething Pain

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-738
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 100 mg

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
GELATIN
Mineral Oil
PECTIN
petrolatum
polyethylene glycol
FD&C RED NO. 40
saccharin sodium

Product Characteristics

Color
red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5.1 in 1 TUBE
2 NDC:10237-738-18 1 in 1 CARTON
3 NDC:10237-738-19 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-06-18


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Be sure to consult your doctor before taking any medication!
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