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

Orajel 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 ingredient         

Benzocaine 7.5%

Purpose

Purpose

Oral Pain Reliever

Uses

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 our child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use more than directed, for more than 7 days unless told to do so 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 persist, consult your physician.

Stop use and ask a physician 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
  • hold swab with solid white tip down
  • bend and snap open swab tip at the colored rings.  Throw away the broken off end before use.  Wait 30-40 seconds for product to flow down into swab tip
  • apply to the affected area up to 4 times daily or as directed by a physician or healthcare provider
  • for infants under 2 years of age,consult a physician or healthcare provider


Other information do not use if label seal is broken prior to purchase, or if colored rings on tip of swab are not pink

Inactive ingredients flavor, polyethylene glycol, purified water, red 33, sodium saccharin

Principal Display

No.1 TEETHING BRAND
recommended by Pediatricians

Orajel

Instant Relief
for Teething Pain

SINGLE USE SWABS                                                       berry flavored swabs
with convenient carrying case

12 UNIT-DOSE SWABS                                                    BENZOCAINE 7.5%
NET 0.06 FL OZ (1.8mL) TOTAL          ORAL PAIN RELIEVER FOR TEETHING                

carton imagePrincipal Display

Orajel Instant Relief for Teething Pain

Benzocaine SWAB

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-736
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine .075 mL

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol
water
D&C RED NO. 33
saccharin sodium

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1.8 in 1 APPLICATOR
2 NDC:10237-736-12 12 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-08-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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