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NDC 36800-0299-86 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 Topco Associates LLC. The primary component is CETYLPYRIDINIUM CHLORIDE.

Product Information

NDC	36800-0299
Product ID	36800-299_e6ad046c-c421-4eaf-a511-26b165ff0660
Associated GPIs
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	Topco Associates LLC
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 36800-0299-86 (36800029986)

Pricing Information	N/A
NDC Package Code	36800-299-86
Billing NDC	36800029986
Package	1000 mL in 1 BOTTLE, PLASTIC (36800-299-86)
Marketing Start Date	1993-08-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 857e8bc4-125f-4796-ac10-6880702816fe Details

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

USE

helps control plaque that leads to gingivitis

Warnings

for this product only

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.

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

Questions?

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

TopCare everyday

Kills germs for better oral hygiene
Helps reduce plaque bacteria
Helps prevent gingivitis
Freshens breath

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

This is not harmful, and adequate brushing may prevent its occurence

*This product is not manufactured or distributed by Procter & Gamble distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROOVE VILLAGE, IL 60077

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

This Top Care product is laboratory tested to guarantee its hightest quality. Your total satisfaction is guaranteed.

principal display panel

COMPARE TO CREST PRO-HEALTH MOUTH RINSE

TopCare everyday

ALCOHOL FREE ORAL HEALTH Mouthwash

ANTIGINGIVITIS / ANTIPLAQUE

MINT

Kills germs for better oral hygiene
Helps reduce plaque bacteria
Helps prevent gingivitis
Freshens breath

33.8 FL OZ (1 qt 1.8 FL OZ) 1L

INGREDIENTS AND APPEARANCE

ANTISEPTIC

cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-299
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
Packaging
1	NDC:36800-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/1993
2	NDC:36800-299-21	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/1993
3	NDC:36800-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/1993

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/03/1993

Labeler - Topco Associates LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-299)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-299)

Revised: 8/2022

Document Id: e6ad046c-c421-4eaf-a511-26b165ff0660

Set id: 857e8bc4-125f-4796-ac10-6880702816fe

Version: 11

Effective Time: 20220805