Active Ingredients
Hydrogen peroxide 1.5% (w/v)
Menthol 0.1% (w/v)
Oral Sore Antiseptic Liquid
FDA Label NDC 11822-3024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Oral Sore Antiseptic (NDC 11822-3024). 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
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
Adverse Reactions Section
This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse for all Mouth Sores
SATISFACTION GUARANTEE
If you're not satisfed, we'll happily refund your money.
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com
Principal Display Panel
Sealed with printed neckband for your protection
Compare to Orajel Antiseptic Rinse for all Mouth Sores
ORAL SORE ANTISEPTIC RINSE
TEMPORARY PAIN RELIEF FOR MOUTH SORES
MINT
for mouth sores, including gum irritation from braces or dentures and canker sores
kills germs and bacteria
helps alleviate pain
473 mL (16 FL OZ)
Image Description (Mm3)
* Please review the disclaimer below.
