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 Retail Business Services , Llc. 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
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
Other
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 0=20785
1-844-846-9949, 2021 Ahold Delhaze licensing
Quality guarenteed 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
FOR MOUTH SORES, INCLUDING GUM IRRITATIONS FROM BRACES OR DENTURES AND CANKER SORES
MINT FLAVOR
Sealed With Printed Neckband For Your Protection
16 FL OZ (1 PT) 473 mL
* Please review the disclaimer below.