FDA Label for Oral Sore Antiseptic
View Indications, Usage & Precautions
Oral Sore Antiseptic Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Adverse Reactions Section
DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED walgreens.com
MADE IN U.S.A. WITH U.S. AND FOREIGN COMPONENTS
This product is not manufacted or distributed by
Church & Dwight Co., Inc distributor of Orajel Antiseptic Rinse
Principal Display Panel
Walgreens
Compare to Orajel
Antiseptic Rinse
active ingrediets
Antiseptic
Rinse
ORAL PAIN RELIEVER & DEBRIDING AGENT
WITH HYDROGEN PEROXIDE & MENTHOL
CLEANS MOUTH SORES
- For mouth sores, including gum irritation from braces or dentures & canker sores
- Temporary pain relief for mouth sores
- Kills germs & bacteria
16 FL OZ (473 mL)
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
* Please review the disclaimer below.