Orajel ™

Drug Facts

Composition & Product

Active Ingredients

Menthol, Unspecified Form (1 mg) Hydrogen Peroxide (15 mg)

Inactive Ingredients

Edetate Disodium Anhydrous Fd&c Blue No. 1 Methyl Salicylate Phosphoric Acid Poloxamer 338 Polysorbate 20 Propylene Glycol Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-01-15

Medication Information

Description

Drug Facts

Uses

first aid to help reduce bacteria in minor oral wounds
for temporary pain relief and
use in cleansing minor wounds or minor gum inflammation resulting from:
- minor dental procedures
- accidental injury
- orthodontic appliances
- canker sores
- dentures
- other irritations of the mouth and gums

Aids in the removal of:

phlegm
mucus
other secretions associated with occasional sore mouth

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Section 50567-7

When using this productdo not swallow

do not exceed recommended dosage

Section 50570-1

Do not usethis product for more than 7 days unless directed by a dentist or healthcare provider

Section 55105-1

Active ingredients	Purpose
Hydrogen peroxide 1.5%	Oral debriding agent/Oral antiseptic
Menthol 0.1%	Oral pain reliever

Directions

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 = 10mL) 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 healthcare provider
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 healthcare provider

Other Information

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

Inactive Ingredients

disodium EDTA, FD&C blue no.1, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water

Questions Or Comments?

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

Stop Use and See Your Physician Promptly If

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

Principal Display Panel 473.2 Ml Bottle Label

1#

ORAL PAIN

RELIEF BRAND

FOR ADULTS

Orajel _™

2X

GUM PAIN RINSE

MEDICATED

ALCOHOL FREE

EFFECTIVE ORAL PAIN RELIEF

Soothes & Cools Gums
Kills Harmful Bacteria
Promotes Healing
Relieves Gum Irritation

Caused by Dentures or Braces

ORAL DEBRIDING AGENT/

ANTISEPTIC RINSE/PAIN RELIEVER

Soothing

MINT

16 FL OZ (473.2 mL)

OJLBF-01904-01 72025286

Structured Label Content

Uses

first aid to help reduce bacteria in minor oral wounds
for temporary pain relief and
use in cleansing minor wounds or minor gum inflammation resulting from:
- minor dental procedures
- accidental injury
- orthodontic appliances
- canker sores
- dentures
- other irritations of the mouth and gums

Aids in the removal of:

phlegm
mucus
other secretions associated with occasional sore mouth

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Section 50567-7 (50567-7)

When using this productdo not swallow

do not exceed recommended dosage

Section 50570-1 (50570-1)

Do not usethis product for more than 7 days unless directed by a dentist or healthcare provider

Section 55105-1 (55105-1)

Active ingredients	Purpose
Hydrogen peroxide 1.5%	Oral debriding agent/Oral antiseptic
Menthol 0.1%	Oral pain reliever

Directions

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 = 10mL) 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 healthcare provider
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 healthcare provider

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

disodium EDTA, FD&C blue no.1, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water

Questions Or Comments? (Questions or comments?)

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

Stop Use and See Your Physician Promptly If (Stop use and see your physician promptly if)

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

Principal Display Panel 473.2 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473.2 mL Bottle Label)

1#

ORAL PAIN

RELIEF BRAND

FOR ADULTS

Orajel _™

2X

GUM PAIN RINSE

MEDICATED

ALCOHOL FREE

EFFECTIVE ORAL PAIN RELIEF

Soothes & Cools Gums
Kills Harmful Bacteria
Promotes Healing
Relieves Gum Irritation

Caused by Dentures or Braces

ORAL DEBRIDING AGENT/

ANTISEPTIC RINSE/PAIN RELIEVER

Soothing

MINT

16 FL OZ (473.2 mL)

OJLBF-01904-01 72025286

Advanced Ingredient Data

[{"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL SALICYLATE", "unii": "LAV5U5022Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 338", "unii": "F75JV2T505", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "first aid to help reduce bacteria in minor oral wounds for temporary pain relief and use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures accidental injury orthodontic appliances canker sores dentures other irritations of the mouth and gums Aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away", "50567-7": "When using this product do not swallow do not exceed recommended dosage", "50570-1": "Do not use this product for more than 7 days unless directed by a dentist or healthcare provider", "55105-1": "Active ingredients Purpose Hydrogen peroxide 1.5% Oral debriding agent/Oral antiseptic Menthol 0.1% Oral pain reliever", "Directions": "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 = 10mL) 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 healthcare provider 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 healthcare provider", "Other information": "cap tightly keep away from heat or direct sunlight do not use if safety seal is broken or missing", "Inactive ingredients": "disodium EDTA, FD&C blue no.1, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water", "Questions or comments?": "call us at 1-800-952-5080 M–F 9am–5pm ET or visit our website at www.orajel.com", "Stop use and see your physician promptly if": "swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days", "PRINCIPAL DISPLAY PANEL - 473.2 mL Bottle Label": "1# ORAL PAIN RELIEF BRAND FOR ADULTS Orajel ™ 2X GUM PAIN RINSE MEDICATED ALCOHOL FREE EFFECTIVE ORAL PAIN RELIEF Soothes & Cools Gums Kills Harmful Bacteria Promotes Healing Relieves Gum Irritation Caused by Dentures or Braces ORAL DEBRIDING AGENT/ ANTISEPTIC RINSE/PAIN RELIEVER Soothing MINT 16 FL OZ (473.2 mL) OJLBF-01904-01 72025286"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information