FDA Label for Antiseptic Oral Cleanser
View Indications, Usage & Precautions
Antiseptic Oral Cleanser Product Label
The following document was submitted to the FDA by the labeler of this product Old East Main Co.. 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 Ingredient (In Each 10 Ml)
Hydrogen Peroxide 150mg
Purpose
Oral debriding agent/Oral wound cleanser
Use
oral debriding agent/oral wound cleanser for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums such as mouth burns, cheek bites and toothbrush abrasions
Warnings
Warnings
Do Not Use This Product
for more than 7 days unless directed by a dentist or physician.
When Using This Product,
do not swallow
Stop Use And Ask A Doctor If
•sore mouth symptoms do not improve in 7 days
• irritation, pain or redness persists or worsens
•swelling, rash or fever develops
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
•rinse half a capful (two teaspoons or 10 mL mark on cap) around in mouth over affected area for at least 1 minute, then spit out
•use up to 4 times daily after meals and at bedtime 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 physician
Other Information
•store at controlled room temperature 20-25⁰ C (68-77⁰F)
Inactive Ingredients
water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, blue 1
Other
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
DISRRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
100% SATISFACTION GUARANTEED (888)- 309-9030
Principal Display Panel
Rexall
Antiseptic Oral Cleanser Hydrogen Peroxide
- Promotes healing of oral irritations
- Oral debriding agent
- Great tasting original flavor
8 FL OZ (236 mL)
* Please review the disclaimer below.