Orajel for Cold Sores Double Medicated, Cream

Manufacturer: Church & Dwight Co., Inc.
Effective date: 2025-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:20:23

Label at a glance#

ProductOrajel for Cold Sores Double Medicated, Cream

Active ingredientBENZOCAINE, PETROLATUM

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1-800-952-5080

Websitewww.orajel.com

www.orajel.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

White petrolatum 73.64%

OTC - QUESTIONS SECTION

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

OTC - PURPOSE SECTION

Topical anesthetic

Skin protectant

INDICATIONS & USAGE SECTION

Usetemporarily relieves pain, itching and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

WARNINGS SECTION

Warnings

For external use only

Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy

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

OTC - DO NOT USE SECTION

Do not use

more than directed
for more than 7 days unless directed by a physician or healthcare provider
for teething
in children under 2 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

cut open tube of tip on score mark
Do not use if tip is cut prior to opening

Adults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

Children betweem 2 and 12 years of age: Ask a doctor before use. Should be supervised in the use of this product

Children under 2 years of age: Do not use

INACTIVE INGREDIENT SECTION

Inactive ingredientscholecalciferol, mineral oil, phenoxyethanol (and) hydroxyacetophenone (and) caprylyl glycol (and) water, propylene glycol, prunella vulgaris leaf extract, retinyl palmitate (vitamin A palmitate), tocopherol, tocopherol acetate (vitamin E acetate), zea mays (corn) oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL PAIN

RELIVER

BRAND

FOR ADULTS

2 Active

Ingredients

Orajel

Instant Pain Relief

FOR COLD SORES

Fast-Acting Cream

DOUBLE MEDICATED

Relieves Pain & Itching

Moisturizing Barrier Stays in Place

Paraben Free

TOPICAL ANESTHETIC/SKIN PROTECTANT

NET WT 0.125 OZ (3.5 g)

Label.jpg

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10237-797-12	Orajel for Cold Sores Double Medicated, Cream	3.5 g in 1 TUBE	CREAM	3.5		5
10237-797-12	Orajel for Cold Sores Double Medicated, Cream	1 in 1 CARTON	CREAM	1		5

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Orajel for Cold Sores Double Medicated, Cream
Benzocaine and White Petrolatum
CHOLECALCIFEROL
METHYLPARABEN
MINERAL OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
PRUNELLA VULGARIS FLOWERING TOP
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE, D-
WATER
CORN OIL
BENZOCAINE
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10237-797	10237-797-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHOLECALCIFEROL	1C6V77QF41	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MINERAL OIL	T5L8T28FGP	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PRUNELLA VULGARIS FLOWERING TOP	ID3IB81B1C	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
WATER	059QF0KO0R	IACT
CORN OIL	8470G57WFM	IACT
BENZOCAINE	U3RSY48JW5	ACTIB
PETROLATUM	4T6H12BN9U	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orajel for Cold Sores Double Medicated, Cream	BENZOCAINE AND WHITE PETROLATUM	Church & Dwight Co., Inc.	b8699a40-8464-ca02-e053-2995a90a4260	2025-12-05	Warnings	Exact identifier ndc (package): 10237-797-12 ndc (product): 10237-797 ndc11 (package): 10237079712 spl id: 45382973-75d6-bf98-e063-6294a90a50fc spl set id: b8699a40-8464-ca02-e053-2995a90a4260

Reported adverse events (FAERS/openFDA)#

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