ORAJEL INSTANT RELIEF FOR TEETHING PAIN COOLING CUCUMBER- benzocaine 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 Instant Relief for Teething Pain - Cooling Cucumber

Active Ingredient

Benzocaine 7.5%

Purpose
Oral pain reliever

Use

for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.

Allergy Alert

do not use this product if our child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use

more than directed, for more than 7 days unless directed 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 persist, consult your physician.

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 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 children under 2 years of age, consult a physician or healthcare provider

Inactive ingredients  ammonium glycyrrhizate, cucumis sativus (cucumber) fruit extract, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium saccharin, sorbic acid, sorbitol, sucralose


Questions or comments?  call us at 1-800-952-5080 Mon-Fri 9am-5pm ET or visit our website at www.orajel.com


Other information

Do not use if tube tip is cut prior to opening

Stop use and ask a dentist of doctor if

sore mouth symptoms do not improve in 7 days, irritation, pain or redness does not go away, swelling, rash or fever develops

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

Principal Display Carton

NO 1 TEETHING BRAND

recommended by Pediatricians

Orajel

Instant Relief


for Teething Pain dye free melon flavored gel

CONTAINS CUCUMBER EXTRACT KEEP IN REFRIGERATOR FOR EXTRA COOLING

COOLING CUCUMBER

COOLS AND SOOTHES TENDER GUMS




NET WT 0.33 OZ (9.4G) GEL ORAL PAIN RELIEVER FOR TEETHING BENZOCAINE 7.5%



BOJFC-31813-04

ORAJEL INSTANT RELIEF FOR TEETHING PAIN  COOLING CUCUMBER
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-714
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
CUCUMBER (UNII: YY7C30VXJT)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-714-331 in 1 CARTON06/15/201012/31/2019
19.4 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 finalpart35606/15/201012/31/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-714)

Revised: 1/2020
 
Church & Dwight Co., Inc.