BABY ORAJEL NATURALS REMEDY FOR TEETHING PAIN RELIEF- eugenol gel 
Church & Dwight Co., Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Baby Orajel Naturals Drug Facts

Active ingredients

Eugenol 1.2%

Purpose

Oral pain reliever

Use   temporarily relieves 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 dentist or doctor
When using this product
  • fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If symptoms do not go away, advise your dentist or doctor.
Stop use and ask a dentist or doctor if
  • sore mouth symptoms do not get better 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 Baby Orajel
  • apply to the affected area up to four times daily or as directed by a dentist or doctor
  • for infants under 4 months of age, ask a dentist or doctor
Other information
Do not use if tube tip is cut prior to opening

Inactive ingredients   flavor, glycerin, polyethylene glycol, sorbic acid, sorbitol, sucralose, water

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 BRAND USED BY PEDIATRICIANS

Baby Orajel
Naturals

Remedy for Teething Pain Relief

ORAL PAIN RELIEVER FOR TEETHING

benzocaine-free   dye-free   alcohol-free

clove oil formula to soothe swollen gums

EUGENOL 1.2%

NET WT 0.33 OZ (9.4G) GEL

Carton imageCarton image

BABY ORAJEL NATURALS  REMEDY FOR TEETHING PAIN RELIEF
eugenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-718
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL12 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-718-331 in 1 CARTON
19.4 g in 1 TUBE
2NDC:10237-718-341 in 1 CARTON
29.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35612/15/201004/24/2012
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture

Revised: 4/2011
 
Church & Dwight Co., Inc.