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NDC 30142-0576-86 Oral Antivavity 10.41 mg/mL Details

Oral Antivavity 10.41 mg/mL

Oral Antivavity is a ORAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by Kroger Co. The primary component is SODIUM FLUORIDE.

Product Information

NDC	30142-0576
Product ID	30142-576_32e82163-ce81-461f-b2c0-ef4245f59340
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	Oral Antivavity
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	ORAL
Active Ingredient Strength	10.41
Active Ingredient Units	mg/mL
Substance Name	SODIUM FLUORIDE
Labeler Name	Kroger Co
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0576-86 (30142057686)

Pricing Information	N/A
NDC Package Code	30142-576-86
Billing NDC	30142057686
Package	1000 mL in 1 BOTTLE, PLASTIC (30142-576-86)
Marketing Start Date	2015-02-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 932723b8-9875-4f37-8c11-018c94ae0ae1 Details

claims

Kroger

FROM OUR FAMILY TO YOURS

Refreshing

Mint

ALCOHOL FREE FLUORIDE MOUTHWASH

Active ingredient

Sodium fluoride 0.0219% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

For this product

Keep out of reach of children

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 of age and older:

use twice a day after brushing your teeth with a toothpaste
vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using witout supervision
children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, flavor, cetlpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, blue 1

Questions or comments?

1-800-632-6900

Claims

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

Disclaimer

CREST IS A REGISTERED TRADEMARK OF THE PROCTER & GAMBLE COMPANY, CINCINNATI, OHIO 45202. THE PROCTER & GAMBLE COMPANY IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

Adverse Reactions

DISTRIBUTED BY THE KROGER CO., OHIO 452020

QUALITY GUARANTEE

www.kroger.com

principal display panel

COMPARE TO

the active ingredient of

CREST PRO-HEALTH COMPLETE

ANTICAVITY FLUORIDE RINSE

See Back Label

Kroger

Refreshing Mint

ALCOHOL-FREE

FLUORIDE MOUTHWASH

ANTICAVITY FLUORIDE RINSE

IMPORTANT: read directions for proper use.

Helps Prevent Cavities
Helps Make Enamel Stronger
Helps Clean the Entire Mouth
Helps Kill Germs that Cause Bad Breath
Helps Freshen Breath
No Alcohol Burn

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

33.8 FL OZ (1 L)

INGREDIENTS AND APPEARANCE

ORAL ANTIVAVITY

sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-576
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	10.41 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PHOSPHORIC ACID (UNII: E4GA8884NN)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-576-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/06/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/06/2015

Labeler - Kroger Co (006999528)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(30142-576)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(30142-576)

Revised: 4/2022

Document Id: 32e82163-ce81-461f-b2c0-ef4245f59340

Set id: 932723b8-9875-4f37-8c11-018c94ae0ae1

Version: 11

Effective Time: 20220421