Onral Oral Pain Reliever Mouthwash BENZOCAINE SYKA PHARMA INC. FDA Approved Uses For the temporary relief of minor irritation, pain, sore mouth, and sore throat.
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Substance Benzocaine
Route
ORAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Benzocaine 5% Purpose Oral Pain Reliever
Inactive Ingredients
Inactive ingredients: Purified water Vegetable glycerin PEG 400 Sorbitol Polysorbate 80 Natural orange flavor Potassium sorbate Xanthan gum Citric acid Beta-carotene.
Strengths
5 %
Treats Conditions
Uses For The Temporary Relief Of Minor Irritation Pain Sore Mouth And Sore Throat

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0628942758683
UNII
U3RSY48JW5
Packaging

Package Labeling: Label

Package Descriptions
  • Package Labeling: Label

Overview

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

Indications & Usage

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

Dosage & Administration

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.

Warnings & Precautions
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. Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other "caine" anesthetics. 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. 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 Keep out of reach of children
Purpose

Purpose Oral Pain Reliever

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.

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children


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