Orajel for Cold Sores

Manufacturer
Church & Dwight Co., Inc. | James Alexander Corporation | Berkeley Contract Packaging, LLC
Effective date
2012-04-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:46:49

Label at a glance#

ProductOrajel for Cold Sores Single Dose
Active ingredientBENZALKONIUM CHLORIDE, BENZOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Benzalkonium chloride, 0.13%
Benzocaine, 5%

OTC - PURPOSE SECTION

PURPOSE

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUR OF REACH OF CHILDREN

In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Front

Package Back
Package Back
Package Back

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W72
BENZOCAINEACTIVE INGREDIENTU3RSY48JW52
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y2
BENZOCAINEACTIVE MOIETYU3RSY48JW52
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163022
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-74110237-741-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
96252c55-8028-3482-e053-2a95a90a1d50d0c9a69f-c0fe-4feb-928b-7dc4602185a52019-10-30WarningsExact identifier
spl set id: d0c9a69f-c0fe-4feb-928b-7dc4602185a5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.