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NDC 49035-0971-86 Anticavity 0.02 mg/mL Details

Anticavity 0.02 mg/mL

Anticavity is a ORAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc. The primary component is SODIUM FLUORIDE.

Product Information

NDC	49035-0971
Product ID	49035-971_382d0662-9c97-4773-9932-f8a604f1bae9
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	RINSE
Route	ORAL
Active Ingredient Strength	0.02
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 49035-0971-86 (49035097186)

Pricing Information	N/A
NDC Package Code	49035-971-86
Billing NDC	49035097186
Package	1000 mL in 1 BOTTLE, PLASTIC (49035-971-86)
Marketing Start Date	2015-01-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4590ca97-130c-46b2-9ba0-38f4703ef30a Details

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

active ingredients

Sodium fluoride 0.0% (0.01% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warning

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 immediately

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 miute 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

Other information

store at room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
cold weather may temporarily cloud this product

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Questions

Call 1-888-287-1915

guarantee

Satisfaction guaranteed - or we'll replace it or give you your money back. For questions or comments or to report an undersired reaction or side effect, please call 1-888-287-1915

Adverse reactions section

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

971.000/971AA

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Zero Anticavity Mouthwash.

PRINCIPAL DISPLAY PANEL

IMPORTANT: READ DIRECTIONS FOR PROPER USE

equate

Compare to Listerine

Total Care

Zero Anticavity Mouthwash

Alcohol Free

Anticavity

Mouthwash

Sodium Fluoride and Acidulated

Phosphate Topical Solution

Multiple Benefits in One

Helps prevent cavities
Restores enael
Helps strengthen teeth
Help kill bad breath germs
Leves the mouth feeling clean
Freshens breath

Fresh Mint

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTICAVITY

sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-971
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
sorbitol (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHOSPHORIC ACID (UNII: E4GA8884NN)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
menthol (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-971-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/14/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/14/2015

Labeler - Wal-Mart Stores, Inc (051957769)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49035-971)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49035-971)

Revised: 5/2022

Document Id: 382d0662-9c97-4773-9932-f8a604f1bae9

Set id: 4590ca97-130c-46b2-9ba0-38f4703ef30a

Version: 13

Effective Time: 20220510