Orajel Cold Sore Moisturelock

Manufacturer
Church & Dwight Co., Inc.
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:39:13

Label at a glance#

ProductOrajel Cold Sore Moisturelock
Active ingredientBENZOCAINE, ALLANTOIN, CAMPHOR (NATURAL), DIMETHICONE, MENTHOL, PETROLATUM
Label structure12 sections

Dosage and administration

• squeeze tube to dispense • blend well until green tint disappears • rub in gently Adults and children 2 years of age and older | Apply to affected area not more than 3 to 4 times daily Children under 12 years of age | Should be supervised in the use of this product Children under 2 years of age | Ask a physician Other information • do not use if the package is torn, cut or otherwise damaged • store at 15-30ºC (5...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Benzocaine 20%

Camphor 3%

Dimethicone 2%

Menthol 1%

White petrolatum 64%

OTC - PURPOSE SECTION

Allantoin - Skin protectant

Benzocaine - Topical anesthetic

Camphor - Topical analgesic

Dimethicone - Skin protectant

Menthol - Topical analgesic

White petrolatum - Skin protectant

INDICATIONS & USAGE SECTION

Uses •temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

WARNINGS SECTION

For external use only.

Allergy alert:do not use 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

OTC - WHEN USING SECTION

When using this product• do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a physician if• conditions worsens • symptoms do not improve in 7 days • symptoms clear up and occur again within a few days • swelling, rash or fever develops • irritation, pain or redness persists or worsens

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose or allergic reaction, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• squeeze tube to dispense • blend well until green tint disappears • rub in gently

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

Children under 12 years of age | Should be supervised in the use of this product

Children under 2 years of age | Ask a physician

Other information • do not use if the package is torn, cut or otherwise damaged • store at 15-30ºC (59-86º) under dry conditions • this is a personal care item and should be used by one individual only

INACTIVE INGREDIENT SECTION

Inactive Ingredientscaprylic/capric triglyceride, Prunella vulgaris leaf extract. propylene glycol, water, tocopheryl acetate, retinyl palmitate, Zea mays (corn) oil, tocopherol, cholecalciferol, titanium dioxide, yellow 5 lake, iron oxides, blue 1 lake

OTC - QUESTIONS SECTION

Questions or commentscall us at 800 952 5080 Monday through Friday 9 to 5 ET or visit www orajel com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orajel

Instan Pain Relief

FOR COLD SORES

MOISTURELOCK FORMULA

Helps Speed Healing

Treats 6 Symptoms:

1 Pain

2 Itching

3 Redness

4 Scabbing

5 Cracking

6 Dryness

PLUS

Helps Minimize Appearance of Cold Sores

Topical Anesthetic/Topical

Analgesic/Skin Protectant

NET WT 0.105 OZ (3g)

FT_OJBC-99882-04FT_OJBC-99882-04

BK_OJBC-99882-04BK_OJBC-99882-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2257305allantoin 0.5 % / benzocaine 20 % / camphor 3 % / dimethicone 2 % / menthol 1 % / petrolatum 64 % Topical CreamPSN8
2257305allantoin 5 MG/ML / benzocaine 200 MG/ML / camphor 30 MG/ML / dimethicone 20 MG/ML / menthol 10 MG/ML / petrolatum 640 MG/ML Topical CreamSCD8
2257305allantoin 0.5 % / benzocaine 20 % / camphor 3 % / dimethicone 2 % / menthol 1 % / petrolatum 64 % Topical CreamSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-761-01Orajel Cold Sore Moisturelock3 g in 1 TUBECREAM38
10237-761-01Orajel Cold Sore Moisturelock1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-761ORAJEL COLD SORE MOISTURELOCK (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]8Current NDC, Legacy NDC, 2 package rows20241127_3761c7b3-053b-0f50-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-76110237-761-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML · Source PDF

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
Orajel Cold Sore MoisturelockBENZOCAINEChurch & Dwight Co., Inc.3761c7b3-053b-0f50-e054-00144ff88e882024-11-26WarningsExact identifier
ndc (package): 10237-761-01
ndc (product): 10237-761
ndc11 (package): 10237076101
spl id: 27d37e6f-4fd8-ce0e-e063-6394a90ad259
spl set id: 3761c7b3-053b-0f50-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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