Active Ingredients
Cetylpridinium Chloride 0.1% -- Oral Antiseptic
Bioshell
FDA Label NDC 66357-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biofilm, Inc. for the product Bioshell (NDC 66357-120). 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 ingredients, purpose, uses, warnings, directions, keep out of reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Antiseptic
Uses
First aid to help prevent infection in minor oral irritations
Warnings
- Discontinue use and see your dentist or doctor promptly 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.
- Do not use children under 12 years of age
- 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 12 years of age and older: spray into mouth where irritation is present 1 to 3 times, or spray and swish the liquid to affected areas. Expectorate any residual liquid. Use up to 3 times a day, or as directed by a dentist or doctor.
- Children under 12 years of age: consult a dentist or physician.
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 Contol Center right away.
Other Information
Store between 15C and 30C (59F to 86F)
Inactive Ingredients
Purified water, Glycerin, Xylitol, PEG-60 Hydrogenated Castor Oil, PVP-VA S-630 Copolymer, Sodium Benzonate USP/NF/FCC, Potassium Sorbate NF, Xanthan Gum, Sodium Saccharin, Berry Flavor.
Questions Or Comments?
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Bioshell
Bioshell.jpg (Bioshell)
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