Otc - Active Ingredient
Active ingredients
EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%
Mouthwash Liquid
FDA Label NDC 71927-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Orazen Inc for the product Mouthwash (NDC 71927-006). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antigingivitis, Antiplaque
Indications & Usage
Uses
Helps reduce plaque that leads to
- gingivitis
- bleeding gums
Warnings
Warnings
Stop use and see your dentist immediately if
- gingivitis, bleeding or redness persists for more than 2 weeks
- you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth
These may be signs or symptoms of periodontitis, a serious form of gum disease.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age . If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions
| adult and children 12 years of age and older | vigorously swish 20 millliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse. |
| children 6 to 20 years of age | supervise use |
| children uner 6 years of age | do not use |
Other Safety Information
Other information
- not intended to replace brushing or flossing
- store at room temperature (59-77F)
- cold weather may cloud this product, but will not affect its antiseptic properties.
Inactive Ingredient
Inactive ingredients
alcohol (21.6%), benzoic acid, flavor, green 3, poloxamer 407, sodium benzoate, sodium saccharin, sorbitol, water
Package Label.Principal Display Panel
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