Oral Sore Antiseptic HYDROGEN PEROXIDE MENTHOL RETAIL BUSINESS SERVICES, LLC FDA Approved Uses ▪ first aid to help protect against bacterial contamination in minor oral wounds ▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures ▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores ▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouth
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Substance Hydrogen Peroxide
Route
ORAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients Hydrogen peroxide 1.5% (w/v) Menthol 0.1% (w/v)
Inactive Ingredients
Inactive ingredients alcohol (4.1% v/v) blue 1 disodium EDTA methyl salicylate phosphoric acid poloxamer 338 polysorbate 20 sodium saccharin sorbitol water
Strengths
1.5 % 0.1 %
Quantities
473 ml
Treats Conditions
Uses First Aid To Help Protect Against Bacterial Contamination In Minor Oral Wounds For Temporary Pain Relief And Temporary Use In Cleansing Minor Wounds Or Minor Gum Inflammation Resulting From Minor Dental Procedures Dentures Orthodontic Appliances Accidental Injury Other Irritations Of The Mouth And Gums Canker Sores Aids In The Removal Of Phlegm Mucus Other Secretions Associated With Occasional Sore Mouth

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
BBX060AN9V L7T10EIP3A
Packaging

Principal display panel CAREONE Compare to Orajel Antispetic Rinse Mouth Sores* ORAL SORE ANTISEPTIC RINSE ORAL PAIN RELIEVER ORAL DEBRIDING AGENT FOR MOUTH SORES, INCLUDING GUM IRRITATION FROM BRACES OR DENTURES AND CANKER SORES MINT FLAVOR Sealed With Printed Neckband For Your Protection NET 16 FL OZ (1 PT) 473 mL image description

Package Descriptions
  • Principal display panel CAREONE Compare to Orajel Antispetic Rinse Mouth Sores* ORAL SORE ANTISEPTIC RINSE ORAL PAIN RELIEVER ORAL DEBRIDING AGENT FOR MOUTH SORES, INCLUDING GUM IRRITATION FROM BRACES OR DENTURES AND CANKER SORES MINT FLAVOR Sealed With Printed Neckband For Your Protection NET 16 FL OZ (1 PT) 473 mL image description

Overview

Uses ▪ first aid to help protect against bacterial contamination in minor oral wounds ▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures ▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores ▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouth

Indications & Usage

Uses ▪ first aid to help protect against bacterial contamination in minor oral wounds ▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures ▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores ▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouth

Dosage & Administration

Directions Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician Children under 12 years of age - should be supervised in the use of the product Children under 2 years of age - consult a dentist or doctor

Warnings & Precautions
Warnings for this product
Adverse Reactions

ADVERSE REACTION DISTRIBUTED BY ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872 Quality guaranteed or your money back. *This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse Mouth Sores. DSP-TN-21091 DSP-MO-20087

Purpose

Purpose Oral debriding agent/Oral antiseptic Oral pain reliever

When Using

When using this product do not swallow do not use more than 7 days unless directed by a dentist or doctor do not exceed recommended dosage

Stop Use & Ask a Doctor

Stop use and ask a doctor if ▪ sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting ▪ irritation, pain, or redness persists or worsens ▪ swelling, rash, or fever develops ▪ sore mouth symptoms do not improve in 7 days

Keep Out of Reach of Children

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

Storage & Handling

Other information store at controlled room temperature 68-77°F (20-25°C) keep away from heat or direct sunlight


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