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NDC 50804-0299-86 Antiseptic 0.7 mg/mL Details

Antiseptic 0.7 mg/mL

Antiseptic is a ORAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by Perrigo Direct, Inc. The primary component is CETYLPYRIDINIUM CHLORIDE.

Product Information

NDC	50804-0299
Product ID	50804-299_efeaf847-a760-471b-9858-c2c24910941f
Associated GPIs	88300009100915
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Antiseptic
Proprietary Name Suffix	n/a
Non-Proprietary Name	CETYLPYRIDINIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	RINSE
Route	ORAL
Active Ingredient Strength	0.7
Active Ingredient Units	mg/mL
Substance Name	CETYLPYRIDINIUM CHLORIDE
Labeler Name	Perrigo Direct, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0299-86 (50804029986)

Pricing Information	N/A
NDC Package Code	50804-299-86
Billing NDC	50804029986
Package	1000 mL in 1 BOTTLE, PLASTIC (50804-299-86)
Marketing Start Date	1993-09-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4d452c85-8e28-4915-a638-c71fc9cc77d6 Details

claims

GOODSENSE

Alcohol Free Antiseptic Oral Rinse

SEALED WITH PRINTED

NECKBAND FOR YOUR PROTECTION

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

for this product

Stop use and ask a dentist if

gingivitis, bleeding or redness persists for more than 2 weeks
you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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 Control Center right away.

SPL UNCLASSIFIED SECTION

Directions

adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
do not swallow
children 6 years to under 12 years of age: supervise use
children under 6 years of age: do not use

Other information

this rinse is not intended to replace brushing or flossing

Inactive ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

SPL UNCLASSIFIED SECTION

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

This product is not manufactured or distributed by Procter & Gamble, distributor of

Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint

**Killed at least 99% of representative plaque organisms commonly

associated with gingivitis in as little as 15 seconds

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

GoodSense is a registered trademark of L. Perrigo Company.

principal display panel

GOODSENSE

Alcohol Free Antiseptic Oral Rinse

Antigingivitis/Antiplaque

Mint Flavor

Kills 99% of Germs for a healthier Mouth**

Helps prevent Plaque

Helps prevent gingivitis

Helps keep teeth feeling clean

Freshens Breath

No burn of alcohol

Compare to active ingredients of Crest Pro-Health Rinse*

1 LITER (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC

cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-299
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 188 (UNII: LQA7B6G8JG)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
benzoic acid (UNII: 8SKN0B0MIM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/20/1993

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	09/20/1993

Labeler - Perrigo Direct, Inc (076059836)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(50804-299)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		088520668	manufacture(50804-299)

Revised: 10/2022

Document Id: efeaf847-a760-471b-9858-c2c24910941f

Set id: 4d452c85-8e28-4915-a638-c71fc9cc77d6

Version: 15

Effective Time: 20221003

Search by Drug Name or NDC

NDC 50804-0299-86 Antiseptic 0.7 mg/mL Details

Antiseptic 0.7 mg/mL

Product Information

Package

Package Images

NDC 50804-0299-86 (50804029986)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4d452c85-8e28-4915-a638-c71fc9cc77d6 Details

claims

Active ingredient

Purpose

Use

Warnings

Stop use and ask a dentist if

Keep out of reach of children under 6 years of age.

SPL UNCLASSIFIED SECTION

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

principal display panel

INGREDIENTS AND APPEARANCE

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