Orajel Antiseptic Rinse for Mouth Sores

Manufacturer
Church & Dwight Co., Inc. | Church & Dwight Canada Corp.
Effective date
2020-01-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:46:25

Label at a glance#

ProductOrajel Antiseptic Rinse for Mouth Sores
Active ingredientHYDROGEN PEROXIDE
Label structure11 sections

Indications and uses

for temporary use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures orthodontic appliances dentures accidental injury canker sores other irritations of the mouth and gums Aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth

Dosage and administration

remove imprinted safety seal from bottle cap to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed. Adults and children 2 years of age and older Swish one-half capful (2 teaspoons = 10 mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

hydrogen peroxide 1.5%

Purpose

OTC - PURPOSE SECTION

Oral debriding agent

Uses

INDICATIONS & USAGE SECTION

for temporary use in cleansing minor wounds or minor gum inflammation resulting from:

  • minor dental procedures
  • orthodontic appliances
  • dentures
  • accidental injury
  • canker sores
  • other irritations of the mouth and gums

Aids in the removal of:

  • phlegm
  • mucus
  • other secretions associated with occasional sore mouth

Warnings

WARNINGS SECTION

Do not use this product for more than 7 days unless directed by a dentist or doctor

When using this product do not swallow

Stop use

OTC - STOP USE SECTION

Stop use and see your dentist or doctor promptly if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • remove imprinted safety seal from bottle cap
  • to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.

Adults and children 2 years of age and older

  • Swish one-half capful (2 teaspoons = 10 mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

Children under 12 years of age

  • Should be supervised in the use of this product

Children under 2 years of age

  • Consult a dentist or doctor

Other information

OTHER SAFETY INFORMATION

  • cap tightly
  • keep away from heat or direct sunlight
  • do not use if safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (4.1% by volume), blue 1, disodium EDTA, methylparaben, methyl salicylate, phosphoric acid, poloxamer 338, purified water, sodium saccharin, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 ORAL PAIN

RELIEVER BRAND

FOR ADULTS

With

PAIN RELIEF!

Orajel

FOR ALL MOUTH SORES

ANTISEPTIC RINSE

Canker Sores Cheek Bites Gum Irritation

Irritation from Dentures or Braces

Promotes Healing

Kills Bacteria

Provides Pain Relief

ORAL DEBRIDING AGENT/

ANTISEPTIC RINSE/PAIN RELIEVER

16 FL OZ (473.2 mL)

DA2011184_OJLBF-32499-06_72013522DA2011184_OJLBF-32499-06_72013522

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-79310237-793-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
cfe2d4d7-1ab5-07fb-e053-2995a90a4d9d9c0753b4-6dbb-2cf1-e053-2a95a90a0b2a2021-11-03WarningsExact identifier
spl set id: 9c0753b4-6dbb-2cf1-e053-2a95a90a0b2a

Reported adverse events (FAERS/openFDA)#

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