Your browser does not support JavaScript! ORAJEL FOR COLD SORES SINGLE DOSE (BENZALKONIUM CHLORIDE, BENZOCAINE) LIQUID [CHURCH & DWIGHT CO., INC.]
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ORAJEL FOR COLD SORES SINGLE DOSE (benzalkonium chloride, benzocaine) liquid
[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 INGREDIENTS

Benzalkonium chloride, 0.13%
Benzocaine, 5%

PURPOSE

Cold Sore / Fever Blister Treatment; Topical Antiseptic
Pain Relief During Applications

USES
  • to treat cold sores / fever blisters
  • to help guard against infection

WARNINGS

For external use only. Flammable, keep away from fire or flame.

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

Do not use
  • in the eyes
  • over large areas of the body
  • if you are allergic to any ingredient in the product
  • more than 3 times per day
  • longer than one week unless directed by a physician
Stop use and ask a dentist or physician if
  • condition persists or worsens
  • symptoms persist for more than 7 days
Ask a physician if
  • used to treat deep or puncture wounds, animal bites, or serious burns
  • you are pregnant or nursing a baby
When using this product you may feel a brief stinging sensation when applying it. The sting should go away in a short time.

KEEP OUR 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 over 2 years of age:
  • Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using only warm water or alcohol
  • Slide off to remove the protective blue paper cover and slide it on the other end-opposite the white applicator tip
  • Squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap
  • Hold with the white applicator tip down to allow the medication to saturate the tip
  • To minimize pain during application gently touch the site of the cold sore with the saturated applicator tip. Once the area is numb, rub the site of the cold sore and the surrounding area.  Rub firmly to allow the treatment to deeply penetrate the skin.
  • To treat most cold sores, usually one treatment is enough.  If your symptoms go away and then return later, apply another dose for the second cold sore
  • Do not use more than 3 times per day
  • Discard after use.
Children under 2 years of age: ask a dentist or physician.

OTHER INFORMATION
  • Store at room temperature
  • The ingredients in toothpaste, soft drinks, and some fruit juices can de-activate the active ingredient in Orajel Single Dose.
  • For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for one hour after applying the drug.

INACTIVE INGREDIENTS
isopropyl alcohol (70% v/v), water

Questions or coments? call us at 1-800-952-5080 M-F ET or visit our website at www.orajel.com

NEW
Orajel

Instant Pain Relief

FOR COLD SORES

ONE DAY, ONE DOSE,
HEALING BEGINS

SINGLE DOSE
Patented Cold Sore Treatment

CONTAINS 2 ONE DAY TREATMENT VIALS         TOPICAL ANTISEPTIC/TOPICAL ANESTHETIC
NET 0.04 FL OZ (1.2 mL) Total                                TOUCH-FREE APPLICATOR

Package Front
Package Front

Package Back
Package Back
ORAJEL FOR COLD SORES  SINGLE DOSE
benzalkonium chloride, benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10237-741
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
BENZOCAINE (BENZOCAINE) BENZOCAINE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-741-042 in 1 PACKAGE
10.6 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/2012
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander Corporation040756421manufacture
Establishment
NameAddressID/FEIBusiness Operations
Berkeley Contract Packaging, LLC807293576pack

Revised: 4/2012
 
Church & Dwight Co., Inc.

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