Orajel Severe Toothache Gum Relief - Triple Medicated Cream

Manufacturer
Church & Dwight Co., Inc.
Effective date
2021-06-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:43:40

Label at a glance#

ProductBenzocaine, Menthol, Zinc Chloride
Active ingredientBENZOCAINE, ZINC CHLORIDE, MENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Menthol 0.25%

Zinc Chloride 0.15%

OTC - PURPOSE SECTION

Benzocaine - Oral Pain Reliever

Menthol - Oral Pain Reliever

Zinc Chloride - Oral Astringent

INDICATIONS & USAGE SECTION

Use • or temporary relief of oral pain due to minor irritation or injury of the mouth and gums

WARNINGS SECTION

Warnings

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

OTC - STOP USE SECTION

Stop use and ask a physician if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days if allergic reaction occurs.

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 • cut open tip of tube on score mark

Adults and children 2 years of age and over:

Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a physician or healthcare provider

Children under 12 years of age:

Should be supervised in the use of this product

Children under 2 years of age:

Ask a physician or healthcare provider

Other Information • do not use if tube tip is cut prior to opening • do not use continuously • cream will stay in place for extended duration of relief

INACTIVE INGREDIENT SECTION

Inactive Ingredients • cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene, glycol, sodium saccharin, water

OTC - QUESTIONS SECTION

Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 or visit our website at www orajel com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1

ORAL PAIN

RELIEVER BRAND

FOR TOOTHACHE

New Formula!

3X MORE

Active Ingredients*

Orajel™

Instant Pain Relief

SEVERE

Toothache & Gum Relief Plus

TRIPLE MEDICATED

• 20% Benzocaine to Relieve Oral Pain

• Astringent to Relieve Gum Irritation NEW

• Menthol to soothe gums

LONG-LASTING

CREAM

Oral Pain Reliever/Astringent

NET WT 0.33 OZ (9.4g)

OJFC-32501-09_CREAMOJFC-32501-09_CREAM

Products#

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DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-76810237-768-33, 10237-768-25

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
c46eda69-8929-fec5-e053-2a95a90a955c4c71b852-793e-4e8d-e054-00144ff8d46c2021-06-10WarningsExact identifier
spl id: c46eda69-8929-fec5-e053-2a95a90a955c
spl set id: 4c71b852-793e-4e8d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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