FDA Label for Antiseptic Mouth Sore
View Indications, Usage & Precautions
Antiseptic Mouth Sore Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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
Hydrogen peroxide 1.5%
Menthol 0.1%
Purpose
Oral debriding agent/Oral wound cleansing
Oral pain reliever
Uses
• For temporary use in cleansing minor wounds or gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, canker sores, or other irritations of the mouth and gums.• For temporary relief of pain associated with canker sores
Do Not Use
this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, stop use and see your dentist or doctor promptly.
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 and older
• Swish one-half capful (2 teaspoons=10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor. Do not swallow.• Children under 12 years of age should be supervised in the use of this product.
Children under 2 years of age: Consult a dentist or doctor.
Other Information
• Do not use if printed safety seal is broken or missing• Recommended storage temperature 59°-77°F (15°-25°C)
Inactive Ingredients
Purified Water, Sorbitol, Poloxamer 407, PEG-40 Hydrogenated Castor Oil, Flavor, Sodium Benzoate, Sodium Saccharin, Xylitol, Citric Acid
Package/Label Principal Display Panel
ALCOHOL FREE
CVS Health®
Compare to the active ingredients in Orajel® Antiseptic Rinse
Antiseptic Mouth Sore Rinse
ORAL DEBRIDING AGENT / ORAL WOUND CLEANSER
- Dye Free
- Promotes healing & cleans oral wounds
- Relieves pain from canker sores, cheek bites, gum irritation & dental work
Fresh Mint
16 FL OZ (473 mL)
LFA4317F1
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