FDA.reportPublic FDA data

BioShell Oral Antiseptic Spray

Manufacturer
BioFilm Inc | TRI-PAC, INC.
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:05:44

Label at a glance#

ProductBioShell Oral Antiseptic
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

First aid to help prevent infection in minor oral irritations.

Dosage and administration

Adults and children 12 years of age and older Shake well before using 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

Storage and handling

Store between 15C and 30C (59F to 86F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chlroide (0.1%)

Purpose

OTC - PURPOSE SECTION

Oral Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor oral irritations.

Warning - Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach from children.

Warnings

WARNINGS SECTION

Discontinue use and see your dentist or doctor promplty 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.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older
  • Shake well before using
  • 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

Other Information

STORAGE AND HANDLING SECTION

Store between 15C and 30C (59F to 86F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Berry Flavor, Glycerin, PEG-60 Hyrodgenated Castor Oil, Potassium Sorbate, Purified Water, PVP-VA Copolymer, Sodium Benzoate, Sodium Saccharin, Xanthan Gum, Xylitol

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-848-5900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioShell

Germ Defense For your Mouth

Fights & Kills Germs

Oral Antiseptic

Cetylpryidinium Chloride 0.1% [CPC]

Berry Flavor

Alcohol Free

1.0 fl. oz (30ml)

Patented Formula

CartonCartonInner LabelInner Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66357-03066357-030-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
COPOVIDONE K25-31D9C330MD8BIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
de337561-a38c-5e88-e053-2995a90a7eceda6da716-b80e-50db-e053-2a95a90aa6cf2022-05-04WarningsExact identifier
spl set id: da6da716-b80e-50db-e053-2a95a90aa6cf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.