Your browser does not support JavaScript! ORAJEL FOR ALL MOUTH SORES MAXIMUM STRENGTH (BENZOCAINE) SWAB [CHURCH & DWIGHT CO., INC.]
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ORAJEL FOR ALL MOUTH SORES MAXIMUM STRENGTH (benzocaine) swab
[Church & Dwight Co., Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active ingredient          Purpose

Benzocaine 20%                Oral Pain Reliever

Uses for the temporary relief of pain associated with canker sores, cold sores, fever blisters minor irritation or injury of the mouth and gums

Warnings
Allergy Alert
do not use this product if your have 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 told to do so by a dentist or doctor

Stop use and ask a dentist of doctor if sore mouth symptoms do not get better in 7 days; swelling, rash or fever develops; irritation, pain or redness does not go away

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

Adults and Children               Hold swab with solid white tip down
2 years of age and older        Bend and snap open swab tip with the colored rings
                                           Apply product to affected area
                                           Use up to 4 times daily or as directed by a dentist or doctor


Other information do not use if label seal is broken prior to purchase, or if colored rings on tip are not orange
Inactive ingredients flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5

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

Orajel Instant Pain Relief medicated swabs

for all Mouth Sores

Maximum Strength

12 unit-dose Swabs  Net 0.06 FL OZ (1.8 ML) EACH

Carton image

Carton image

ORAJEL FOR ALL MOUTH SORES  MAXIMUM STRENGTH
benzocaine swab
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10237-709
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE0.2 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 
WATER 
FD&C RED NO. 40 
SACCHARIN SODIUM 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-709-1212 in 1 CARTON
11.8 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/01/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
SwabPlus, Inc.876441549manufacture

Revised: 8/2010
 
Church & Dwight Co., Inc.

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