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

Orajel Instant Pain Relief

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

Active ingredient

Active Ingredients       Purpose

Purpose

Use 

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

Do not use
more than is 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, get medical help or contact a Poison Control Center right away

Directions    cut open tip of tube on score mark

Adults and children 2 years of age and over             Apply a small amount of product to the cavity and around gum surrounding the teeth.
                                                                            Use up to 4 times daily or as directed by dentist or doctor.

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

Children under 2 years of age                                  Ask a dentist or doctor


Other information

do not use if tube tip is cut 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
Orajel Severe Pain Formula will stay in place for extended duration of relief


Inactive ingredients cellulose gum, gelatin, methyl salicylate, pectin, plasticized hydrdocarbon gel, polyethylene glycol, sodium saccharin

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

Orajel         Cream
Instant Pain Relief
for SEVERE TOOTHACHE
MAXIMUM STRENGTH
Long Lasting Formula

NET WT 0.33 OZ (9.4 g)    ORAL PAIN RELIEVER


carton image

Orajel Instant Pain Relief

Benzocaine and Menthol CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-702
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 200 mg
MENTHOL 2.5 mg

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
GELATIN
methyl salicylate
PECTIN
Mineral Oil
polyethylene glycol
saccharin sodium

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 9.4 in 1 TUBE
2 NDC:10237-702-33 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-06-10


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