ORAJEL NATURALS FAST RELIEF FOR TEETHING PAIN- 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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Orajel Naturals Drug Facts

Active ingredients

Eugenol 1.2%

Purpose

Oral pain reliever

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

When using this product • fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician.

Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider.

Stop use and ask a physician 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 of 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 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 • do not use if tube tip is cut prior to opening

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

Questions or comments ? call us at 800 952 5080 monday through friday 9-5 or visit our website at www orajelnaturals com

#1 Teething Brand

recommended by Pediatricians

Orajel

Naturals

Fast Relief

for Teething Pain

gel

Clove oil formula to soothe swollen gums

Long Lasting

Benzocaine-Free

Alcohol-Free & Paraben Free

Safety Sealed Tube Tip

BOJFC-32372-03

ORAJEL NATURALS  FAST RELIEF FOR TEETHING PAIN
eugenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-737
Route of AdministrationTOPICALDEA Schedule    
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:10237-737-331 in 1 CARTON
19.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10237-737-341 in 1 CARTON
29.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/15/201003/25/2016
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-737)

Revised: 3/2016
 
Church & Dwight Co., Inc.