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NDC 36800-0803-43 Anticavity 0.2 mg/mL Details

Anticavity 0.2 mg/mL

Anticavity is a ORAL MOUTHWASH 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: 36800-0803-43
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	36800-0803
Product ID	36800-803_70f4a9d3-afa4-43fd-a54d-af63dace630c
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	Anticavity
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	ORAL
Active Ingredient Strength	0.2
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 36800-0803-43 (36800080343)

Pricing Information	N/A
NDC Package Code	36800-803-43
Billing NDC	36800080343
Package	474 mL in 1 BOTTLE, PLASTIC (36800-803-43)
Marketing Start Date	2015-09-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c337c982-bd18-4a1a-851a-fca1551a242e Details

Active Ingredient

Sodium fluoride 0.02% (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 and 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, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information

store at room temperature (59º-77ºF)

other information

Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened.

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Healthy White Vibrant Anticavity Mouthrinse

Adverse reactions

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

[email protected] www.topcarebrand.com

principal display panel

COMPARE TO LISTERINE HEALTHYWHITE

Top Care

everyday

FLUORIDE

Whitening

Antivavity Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

FRESH MINT

5 days to whiter teeth
Begins working on contact
Safely whitens teeth
Kills germs that cause bad breath

IMPORTANT: Read direction for proper use.

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

ANTICAVITY

sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-803
Route of Administration	oral

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-803-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2015
2	NDC:36800-803-43	474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/15/2015

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-803)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-803)

Revised: 4/2022

Document Id: 70f4a9d3-afa4-43fd-a54d-af63dace630c

Set id: c337c982-bd18-4a1a-851a-fca1551a242e

Version: 10

Effective Time: 20220427