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NDC 49035-0435-43 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 Wal-Mart Stores, Inc. 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: 49035-0435-43
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	49035-0435
Product ID	49035-435_8e5ba75b-b3df-4c37-b497-7effe721df59
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	Wal-Mart Stores, Inc
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 49035-0435-43 (49035043543)

Pricing Information	N/A
NDC Package Code	49035-435-43
Billing NDC	49035043543
Package	473 mL in 1 BOTTLE, PLASTIC (49035-435-43)
Marketing Start Date	2015-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9e5806aa-b91a-4b8e-b869-6d6f306d10c9 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)

claims

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

Disclaimer

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

Satisfaction guaranteed- Or we'll replace it or give you your money back. For questions or comments please call 1-888-287-1915

Adverse Reactions

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

principal display panel

equate

Compare to Literine

HeathyWhite

Anticavity Mouthwash

Glowing White

Anticavity

Mouthrinse

Begins working on contact
5 days to whiter teeth
Helps strenghten teeth
Kills germs that cause bad breath

FRESH MINT

IMPORTANT: read directions for proper use.

32 FL OZ (946 mL)

INGREDIENTS AND APPEARANCE

ANTICAVITY

sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-435
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:49035-435-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2015
2	NDC:49035-435-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/01/2015

Labeler - Wal-Mart Stores, Inc (051957769)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49035-435)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49035-435)

Revised: 4/2022

Document Id: 8e5ba75b-b3df-4c37-b497-7effe721df59

Set id: 9e5806aa-b91a-4b8e-b869-6d6f306d10c9

Version: 12

Effective Time: 20220414