BIOSHELL- cetylpridinium chloride spray

BioShell by

Drug Labeling and Warnings

BioShell by is a Otc medication manufactured, distributed, or labeled by BioFilm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Cetylpridinium Chloride 0.1% -- Oral Antiseptic

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?

Call toll-free 1-800-848-5900

BioShell

INGREDIENTS AND APPEARANCE

BIOSHELL 
cetylpridinium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66357-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66357-120-02	1 in 1 BOX	05/02/2022
1	NDC: 66357-120-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/02/2022

Labeler - BioFilm, Inc. (790780258)

Establishment
Name	Address	ID/FEI	Business Operations
BioFilm, Inc.		790780258	manufacture(66357-120)