BioShell Oral Antiseptic Spray

BioShell Oral Antiseptic by

Drug Labeling and Warnings

BioShell Oral Antiseptic by is a Otc medication manufactured, distributed, or labeled by BioFilm Inc, TRI-PAC, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOSHELL ORAL ANTISEPTIC- cetylpyridinium chloride liquid 
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 Oral Antiseptic Spray

Active Ingredient

Cetylpyridinium Chlroide (0.1%)

Purpose

Oral Antiseptic

Uses

First aid to help prevent infection in minor oral irritations.

Warning - Children

Keep out of reach from children.

Warnings

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

• 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

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

Inactive Ingredients

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?

Call toll-free 1-800-848-5900

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

BIOSHELL ORAL ANTISEPTIC 
cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66357-030
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
XYLITOL (UNII: VCQ006KQ1E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66357-030-01	1 in 1 CARTON	03/17/2022
1		30 mL in 1 BOTTLE, DISPENSING; 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	03/17/2022	05/04/2022

Labeler - BioFilm Inc (790780258)

Establishment
Name	Address	ID/FEI	Business Operations
TRI-PAC, INC.		020844956	manufacture(66357-030)

Revised: 5/2022

Document Id: de337561-a38c-5e88-e053-2995a90a7ece

34390-5

Set id: da6da716-b80e-50db-e053-2a95a90aa6cf

Version: 2

Effective Time: 20220504