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

Orajel Naturals

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
Orajel Naturals Drug Facts



FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients

Eugenol 1.2%

Purpose

Purpose

Oral pain reliever

Uses

Use   for the temporary relief of sore gums due to teething in infants and children 4 months or age and older

Warnings

Allergy alert:  do not use this product if your baby has a history of allergy to clove, its components eugenol, or to Balsam of Peru

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 persists, consult your physician.
Stop use and ask a dentist or 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 to 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 Naturals 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 infants under 4 months of age, ask a physician or healthcare provider
Other information

Inactive ingredients

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

No. 1 TEETHING RAND
recommended by Pediatricians

Orajel
Naturals

Fast Relief
for Teething Pain

clove oil formula to soothe swollen gums

LONG LASTING            Benzocaine-Free   Alcohol-Free   Paraben-Free


 NET WT 0.33 OZ (9.4G) GEL            ORAL PAIN RELIEVER FOR TEETHING EUGENOL 1.2%


Carton image

Orajel Naturals

Eugenol GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-737
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Eugenol 12 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
polyethylene glycol 400
POLYETHYLENE GLYCOL 3350
sorbic acid
sorbitol
Sucralose
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 9.4 in 1 TUBE
2 9.4 in 1 TUBE
3 NDC:10237-737-34 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-12-15


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Be sure to consult your doctor before taking any medication!
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