ORAJEL INSTANT PAIN RELIEF MAXIMUM STRENGTH- 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.

----------

Drug Facts

Active Ingredients                  
Benzalkonium chloride 0.02%           
Benzocaine 20%                             
Zinc chloride 0.1%                          

Purpose

Purpose
Oral antiseptic
Oral pain reliever
Pral astringent

Use    for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums. To help protect against infection in minor oral irritation.

Warnings

Allergy Alert
do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzcaine or other "caine" anesthetics

Do not use
more than is directed
for more than 7 days unless directed by a dentist or doctor

Stop use and ask a doctor if
sore mouth symptoms do not improve in 7 days
swelling, rash or fever develops
irritation, pain or redness persists or worsens


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    cut open tip of tube on score mark,  do not use if tube tip is cut prior to opening

Adults and children 2 years of age and over             Apply to affected are up to 4 times daily or as directed by dentist or doctor.

Children under 12 years of age                                Should be supervised in the use of the product

Children under 2 years of age                                  Ask a dentist or doctor

Inactive ingredients allantoin, carbomer, edetate disodiu, mentha piperota (peppermint) oil, polyethylene glycol, polysorbate 60, propylene glycol, propyl gallate, purified water, pvp, sodium saccharin, sorbic acid, stearyl alcohol


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

Principal Display - carton

TRIPLE MEDICATED for FAST
EFFECTIVE RELIEF  

               
Orajel                  gel
Instant Pain Relief
For all Mouth Sores

MAXIMUM STRENGTH

SAFETY SEALED TUBE TIP
NET WT 0.125 OZ (3.5g)            ORAL PAIN RELIEVER / ORAL ANTISEPTIC / ORAL ASTRINGENT

carton imagecarton image

ORAJEL INSTANT PAIN RELIEF  MAXIMUM STRENGTH
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-708
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.4 mg  in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC - UNII:J41CSQ7QDS) ZINC CHLORIDE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
CARBOMER 934 (UNII: Z135WT9208)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
POVIDONE K30 (UNII: U725QWY32X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-708-421 in 1 CARTON
111.9 g in 1 TUBE
2NDC:10237-708-181 in 1 CARTON
25.1 g in 1 TUBE
3NDC:10237-708-121 in 1 CARTON
33.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/11/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture

Revised: 3/2012
Document Id: 2334b033-51b1-4f69-921d-d546aaf3638a
Set id: 1463de61-91ba-4bac-a43a-f0d7ceeee0d0
Version: 2
Effective Time: 20120320
 
Church & Dwight Co., Inc.