Oral Sore Antiseptic Liquid
FDA Label NDC 72476-024

12 label sections · Submitted to the FDA by Retail Business Services, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Retail Business Services, Llc for the product Oral Sore Antiseptic (NDC 72476-024). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, stop use and ask a doctor if, when using this product, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Hydrogen peroxide 1.5% (w/v)

Menthol 0.1% (w/v)

Purpose

Oral debriding agent/Oral antiseptic
Oral pain reliever

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

Warnings

for this product

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

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

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

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

Other Information

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

Inactive Ingredients

alcohol (4.1% v/v), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

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

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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

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