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Drug Facts
Aqua Blue Mouthwash
FDA Label NDC 73563-022
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Body One Products Inc for the product Aqua Blue Mouthwash (NDC 73563-022). 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 other, otc - purpose, use, otc - do not use, otc - stop use, otc - 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
Otc - Purpose
| Active ingredient | Purpose |
|---|---|
| Eucalyptol 0.092% | Antiplaque/Antigingivitis |
| Menthol 0.042% | Antiplaque/Antigingivitis |
| Methyl Salicylate 0.060% | Antiplaque/Antigingivitis |
| Thymol 0.064% | Antiplaque/Antigingivitis |
Use
helps control plaque that leads to gingivitis
Otc - Do Not Use
Do not use if you have painful or swollen gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontis, a serious form of gum disease.
Otc - Stop Use
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks
Otc - Keep Out Of Reach Of Children
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
- do not swallow
- not intended to replace brushing or flossing.
| Adults and children 12 years of age and older | Vigorously swish 20mL between teeth twice a day for 30 seconds then spit out. |
| children under 12 years of age | consult a dentist or doctor |
Other Information
Store at room temperature (59°-77°F).
Inactive Ingredients
Water,Alcohol (21.6%),Polysorbate 80,Sorbitol,Flavor,Benzoic Acid,Sodium Saccharin,Sodium Benzoate,Blue 1,Yellow 5
Principal Display Panel - 128 Fl.Oz. Jug Label
BodyOne
Products
AQUA ⚬ BLUE
MOUTH WASH
1 U.S. Gallon (128 FL.OZ.)
Principal Display Panel (128 FL.OZ. Jug Label)
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