Oral Sore Antiseptic Liquid
FDA Label NDC 37808-024

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Oral Sore Antiseptic (NDC 37808-024). 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, when using this product, keep out of reach of children, directions, other information, 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 mouthUses
▪ 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

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

Safety Seal

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Questions

Call 1-800-925-4733

Other

This product is not manufacted or distributed by Church & Dwight Co., Inc distributor of Orajel*

Made with pride and care for HEB San Antonio, TX 78204

024.000/024AA

Principal Display Panel

Compare to Orajel*

HEB Oral Sore Antiseptic Rinse

ORAL PAIN RELIEVER & DEBRIDING AGEN WITH HYDROGEN PEROXIDE & MENTHOL

  • For mouth sores, including gum irritation from braces or dentures & canker sores
  • Temporary pain relief for mouth sores

    • 16 FL OZ (473 mL)

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    Image Description (Mm3)

    Image Description (Mm3)

* Please review the disclaimer below.