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← See all Orajel for Cold Sores Single Dose brands

Orajel for Cold Sores Single Dose

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 0.13mg in 1g, BENZOCAINE 0.5mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-756

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.

Orajel for Cold Sores SINGLE DOSE

ACTIVE INGREDIENTS

Benzalkonium chloride, 0.13%
Benzocaine, 5%

PURPOSE

Topical Antiseptic
Pain Reliever

USES

  • to treat cold sores / fever blisters

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 this 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 you apply it.  The sting should go away in a short time.

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 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 deactivate 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

Orajel
Instant Pain Relief

FOR COLD SORES

Serious Relief for Serious Cold Sores

SINGLE DOSE

Patented Cold Sore Treatment

Topical Antiseptic/Topical Anesthetic

Touch-Free Applicator

ORAJEL FOR COLD SORES  SINGLE DOSE
benzalkonium chloride, benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-756
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 mg  in 1 g
BENZOCAINE (BENZOCAINE) BENZOCAINE0.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:10237-756-042 VIAL, SINGLE-DOSE in 1 PACKAGE
10.02 g in 1 VIAL, SINGLE-DOSE
2NDC:10237-756-032 VIAL, SINGLE-DOSE in 1 PACKAGE
20.02 g in 1 VIAL, SINGLE-DOSE
3NDC:10237-756-021 VIAL, SINGLE-DOSE in 1 PACKAGE
30.02 g in 1 VIAL, SINGLE-DOSE
4NDC:10237-756-081 VIAL, SINGLE-DOSE in 1 PACKAGE
40.08 g in 1 VIAL, SINGLE-DOSE
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/FEIOperations
James Alexander Corporation040756421manufacture(10237-756)
Establishment
NameAddressID/FEIOperations
Berkeley Contract Packaging, LLC807293576pack(10237-756)

 
Church & Dwight Co., Inc.

← See all Orajel for Cold Sores Single Dose brands

Medically reviewed on Aug 2, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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