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NDC 36800-0482-86 Alcohol-Free Anticavity 0.219 mg/mL Details

Alcohol-Free Anticavity 0.219 mg/mL

Alcohol-Free Anticavity is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO Associates LLC. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 36800-0482-86
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	36800-0482
Product ID	36800-482_e7774d7c-4eff-4c79-8a22-cea6f617146e
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	Alcohol-Free Anticavity
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	0.219
Active Ingredient Units	mg/mL
Substance Name	SODIUM FLUORIDE
Labeler Name	TOPCO Associates LLC
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 36800-0482-86 (36800048286)

Pricing Information	N/A
NDC Package Code	36800-482-86
Billing NDC	36800048286
Package	1000 mL in 1 BOTTLE, PLASTIC (36800-482-86)
Marketing Start Date	2013-09-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ade7dcb2-b4e2-4cef-b9a7-469867ead68a Details

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

SPL UNCLASSIFIED SECTION

Warnings

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 daily 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 without supervision
children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

SPL UNCLASSIFIED SECTION

Sealed with printed neckband for your protection

Topcare everyday

Helps strengthen enamel
Helps prevent cavities
Kills bad breath germs
Freshens breath

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 Complete Anticavity Fluoride Rinse

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139 [email protected] www.topcarebrand.com

principal display panel

Compare to Crest Pro-Health Advanced Anticavity Fluoride Mouthwash*

Topcare everyday

Alcohol free Fluoride Anticavity Mouthwash

Violet mint

Helps strengthen enamel
Helps prevent cavities
Helps keep mouth feeling clean
Kills bad breath germs
Freshens breath

IMPORTANT: read directions for proper use.

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

INGREDIENTS AND APPEARANCE

ALCOHOL-FREE ANTICAVITY

sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-482
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.219 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-482-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/19/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/19/2013

Labeler - TOPCO Associates LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-482)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-482)

Revised: 3/2022

Document Id: e7774d7c-4eff-4c79-8a22-cea6f617146e

Set id: ade7dcb2-b4e2-4cef-b9a7-469867ead68a

Version: 16

Effective Time: 20220307

Search by Drug Name or NDC

NDC 36800-0482-86 Alcohol-Free Anticavity 0.219 mg/mL Details

Alcohol-Free Anticavity 0.219 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 36800-0482-86 (36800048286)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ade7dcb2-b4e2-4cef-b9a7-469867ead68a Details

Active ingredient

Purpose

Use

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Directions

Inactive ingredients

SPL UNCLASSIFIED SECTION

principal display panel

INGREDIENTS AND APPEARANCE

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