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Name:Baby Orajel Naturalsremedy For Teething Pain Relief
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Baby Orajel Naturals Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:10237-718
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUGENOL (EUGENOL) EUGENOL 12 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
POLYETHYLENE GLYCOL 400  
POLYETHYLENE GLYCOL 3350  
SORBIC ACID  
SORBITOL  
SUCRALOSE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-718-33 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 9.4 g in 1 TUBE This package is contained within the CARTON (10237-718-33)
2 NDC:10237-718-34 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
2 9.4 g in 1 TUBE This package is contained within the CARTON (10237-718-34)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part356 12/15/2010

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Church & Dwight Co., Inc. 043690812 manufacture

Revised: 04/2011 Church & Dwight Co., Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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