Orajel for Cold Sores by Church & Dwight Co., Inc. / James Alexander Corporation / Berkeley Contract Packaging, LLC Orajel for Cold Sores

Orajel for Cold Sores by

Drug Labeling and Warnings

Orajel for Cold Sores by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., James Alexander Corporation, Berkeley Contract Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAJEL FOR COLD SORES SINGLE DOSE- benzalkonium chloride, benzocaine liquid 
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.

----------

Orajel for Cold Sores

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 DRUGItem Code (Source)NDC: 10237-741
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10237-741-042 in 1 PACKAGE07/01/201210/30/2019
10.6 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/201210/30/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander Corporation040756421manufacture(10237-741)

Revised: 10/2019
 
Church & Dwight Co., Inc.