Onral Oral Pain Reliever Mouthwash

Onral Oral Pain Reliever Mouthwash
SPL v1
SPL
SPL Set ID 5dd8d933-6f32-4eaf-8eca-9365d7de55a2
Route
ORAL
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (50 mg)
Inactive Ingredients
Water Polyethylene Glycol 400 Sorbitol Polysorbate 80 Potassium Sorbate Xanthan Gum Citric Acid Monohydrate Beta Carotene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Benzocaine 5%

Purpose

Oral Pain Reliever


Medication Information

Purpose

Oral Pain Reliever

Description

Benzocaine 5%

Uses

For the temporary relief of minor irritation, pain, sore mouth, and sore throat.

Warnings

If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentists or doctor promptly.

  • Do not exceed recommended dosage.
Directions
  • Shake well upside down.
  • Gargle, swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out.
  • Children under 12 years of age should be supervised in the use of the product.
  • Apply to the affected area.
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Do not use for teething.
  • Children under 2 years of age: Do not use.
Do Not Use
  • this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other "caine" anesthetics.
Drug Facts

Active Ingredient

Benzocaine 5%

Other Information

store at 68-77 ° F (20-25 ° C)

Package Labeling:

Inactive Ingredients:

Purified water, Vegetable glycerin, PEG 400, Sorbitol, Polysorbate 80, Natural orange flavor, Potassium sorbate, Xanthan gum, Citric acid, Beta-carotene.

Methemoglobinemia Warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce the amount of oxygen carried in blood. This can occur even if you have used this product before.

Keep Out of Reach of Children 

Stop Use and Seek Immediate Medical Attention

if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • rapid heart rate
  • dizziness or lightheadedness
  • headache
  • shortness of breath
  • atigue or lack of energy

Structured Label Content

Uses

For the temporary relief of minor irritation, pain, sore mouth, and sore throat.

Purpose

Oral Pain Reliever

Warnings

If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentists or doctor promptly.

  • Do not exceed recommended dosage.
Directions
  • Shake well upside down.
  • Gargle, swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out.
  • Children under 12 years of age should be supervised in the use of the product.
  • Apply to the affected area.
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Do not use for teething.
  • Children under 2 years of age: Do not use.
Do Not Use (Do not use)
  • this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other "caine" anesthetics.
Drug Facts

Active Ingredient (Active ingredient)

Benzocaine 5%

Other Information (Other information)

store at 68-77 ° F (20-25 ° C)

Package Labeling:

Inactive Ingredients: (Inactive ingredients:)

Purified water, Vegetable glycerin, PEG 400, Sorbitol, Polysorbate 80, Natural orange flavor, Potassium sorbate, Xanthan gum, Citric acid, Beta-carotene.

Methemoglobinemia Warning: (Methemoglobinemia warning:)

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce the amount of oxygen carried in blood. This can occur even if you have used this product before.

Keep Out of Reach of Children  (Keep out of reach of children )

Stop Use and Seek Immediate Medical Attention (Stop use and seek immediate medical attention)

if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • rapid heart rate
  • dizziness or lightheadedness
  • headache
  • shortness of breath
  • atigue or lack of energy

Advanced Ingredient Data


Raw Label Data

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