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Orajel Instant Pain Relief Maximum Strength

Dosage form: gel
Ingredients: BENZALKONIUM CHLORIDE 0.4mg in 1g, BENZOCAINE 200mg in 1g, ZINC CHLORIDE 1mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-708

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 image

ORAJEL INSTANT PAIN RELIEF  MAXIMUM STRENGTH
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-708
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.4 mg  in 1 g
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
ZINC CHLORIDE (ZINC) ZINC CHLORIDE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
CARBOMER 934 
EDETATE DISODIUM 
PEPPERMINT OIL 
POLYETHYLENE GLYCOL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
PROPYL GALLATE 
WATER 
POVIDONE K30 
SACCHARIN SODIUM 
SORBIC ACID 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:10237-708-421 TUBE (TUBE) in 1 CARTON
111.9 g in 1 TUBE
2NDC:10237-708-181 TUBE (TUBE) in 1 CARTON
25.1 g in 1 TUBE
3NDC:10237-708-121 TUBE (TUBE) 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/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

Revised: 03/2012
 
Church & Dwight Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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