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

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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 image

BABY ORAJEL NATURALS  REMEDY FOR TEETHING PAIN RELIEF eugenol   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 10237-718-33 1 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 10237-718-34 1 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: 04/2011Church & Dwight Co., Inc.