BIOSHELL- cetylpridinium chloride spray 
BioFilm, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BioShell

Active ingredients

Cetylpridinium Chloride 0.1% -- Oral Antiseptic

Purpose

Oral Antiseptic

Uses

First aid to help prevent infection in minor oral irritations

Warnings

Directions

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

BioShell.jpg

BIOSHELL 
cetylpridinium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66357-120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66357-120-021 in 1 BOX05/02/2022
1NDC:66357-120-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/02/2022
Labeler - BioFilm, Inc. (790780258)
Establishment
NameAddressID/FEIBusiness Operations
BioFilm, Inc.790780258manufacture(66357-120)

Revised: 3/2022
Document Id: da755149-dd64-5c87-e053-2995a90a1e77
Set id: da755149-dd67-5c87-e053-2995a90a1e77
Version: 2
Effective Time: 20220317
 
BioFilm, Inc.