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NDC 49035-0299-86 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 Wal-Mart Stores, Inc. The primary component is CETYLPYRIDINIUM CHLORIDE.

Product Information

NDC	49035-0299
Product ID	49035-299_0e18c398-a919-45c7-b0f0-e553d2f9055c
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	Wal-Mart Stores, 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 49035-0299-86 (49035029986)

Pricing Information	N/A
NDC Package Code	49035-299-86
Billing NDC	49035029986
Package	1000 mL in 1 BOTTLE, PLASTIC (49035-299-86)
Marketing Start Date	2008-02-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8916fb44-da82-41d5-941a-293ef1d67dd0 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 gum 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
when used after brushing, rinse mouth with water first
children under 6 yearsof 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 1-888-287-1915

SPL UNCLASSIFIED SECTION

Alcohol Free Multi-Action Antiseptic Oral Rinse

Sealed with printed Neckband for your protection

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

Statisfaction guaranteed. For questions or comments please call 1-888-287-1915.

Distributed by Wal-Mart Stores. INC

Bentonville AR72716

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

principal display panel

Equate

Compare to Crest Pro-Health Rinse Multi-Protection Active Ingredient

Alcohol Free Multi-Action Oral Rinse

Antigingivitis/Antiplaque

2X/Day Protection

Kills germs
Helps prevent plaque
Helps prevent gingivitis
Helps keep teeth feeling clean
Freshens breath
No burn of alcohol

Zesty Mint

Use morning & night for better oral hygiene

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC

cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-299
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:49035-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/22/2008
2	NDC:49035-299-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/22/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/22/2008

Labeler - Wal-Mart Stores, Inc (051957769)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(49035-299)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		088520668	manufacture(49035-299)

Revised: 6/2022

Document Id: 0e18c398-a919-45c7-b0f0-e553d2f9055c

Set id: 8916fb44-da82-41d5-941a-293ef1d67dd0

Version: 11

Effective Time: 20220623