Orajel 3X Medicated for Denture Pain - Instant Pain Relief Gel

Manufacturer
Church & Dwight Co., Inc.
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:40:54

Label at a glance#

ProductOrajel 3X Medicated for Denture Pain
Active ingredientBENZOCAINE, MENTHOL, UNSPECIFIED FORM, ZINC CHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Menthol 0.5%

Zinc Chloride 0.15%

OTC - PURPOSE SECTION

Benzocaine - Oral Pain Reliever

Menthol - Oral Pain Reliever

Zinc Chloride - Oral Astringent

INDICATIONS & USAGE SECTION

Use for the temporary relief of • pain due to minor irritation of the mouth and gums caused by dentures • occasional minor irritation, pain, sore mouth

WARNINGS SECTION

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 the 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 heartrate • 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 dentist or doctor • for teething • in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor if • symptoms do not improve in 7 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 a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and overApply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. Apply to affected area up to 4 times daily or as directed by a dentist or doctor
Children between 2 and 12 years of ageAsk a doctor before use. Should be supervised in the use of this product
Children under 2 years of ageDo not use

OTHER SAFETY INFORMATION

do not use if Tamper-Evident Tab is open before first use

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, benzalkonium chloride, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1

ORAL PAIN

RELIEVER BRAND

FOR ADULTS

Ready-Open Tube Tip

Orajel™

3X MEDICATED

FOR DENTURE PAIN

INSTANT PAIN RELIEF

GEL

20% Benzocaine to Relieve Pain from Dentures

Astringent to Relieve Gum Irritation

Menthol to Soothe Gums Irritated by Dentures

OJFC-38405-05.jpgOJFC-38405-05.jpg

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-72310237-723-25

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
27d4128f-9cee-eb42-e063-6394a90a7f0fc480d940-6833-4d91-e053-2995a90ac7812024-11-26WarningsExact identifier
spl set id: c480d940-6833-4d91-e053-2995a90ac781

Reported adverse events (FAERS/openFDA)#

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