Active Ingredient
Cetylpyridinium Chloride 0.05%
Twice. Oral Wellness Gum Shield Rinse
FDA Label NDC 72164-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Twice Twice Llc for the product Twice. Oral Wellness Gum Shield (NDC 72164-009). 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 active ingredient, purpose, uses, warnings, stop use and ask a dentist if, keep out of reach of children, other information, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigingivitis/Antiplaque mouthrinse
Uses
- Helps prevent gingivitis, an early form of gum disease, and bleeding gums
- Helps control plaque that lead to gingivitis and bleeding gums
Warnings
Warnings
Stop Use And Ask A Dentist 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 spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease
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 right away (1-800-222-1222).
Other Information
This rinse is not intended to replace brushing or flossing, Do not use if printed safety seal on the bottle's neck is broken or missing, Recommended storage temperature 59°F-77°F (15°C-25°C)
Directions
Adults and children 12 years of age and older: Vigorously swish 20 mL of rinse between your teeth a day for 30 seconds and then split it our. Do not swallow the rinse.
Children 6 years to under 12 yaers: Supervise use.
Children under 6 years: Do not use.
Inactive Ingredients
Citric Acid, Disodium Phosphate, Glycerin, Lemon Oil, Poloxamer 407, Spearmint Oil, Stevia Leaf Extract, Water
Package Label.Principal Display Panel
00839 (00839.1)
* Please review the disclaimer below.
