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NDC 41250-0971-86 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 Meijer Distribution, Inc. The primary component is SODIUM FLUORIDE.

Product Information

NDC	41250-0971
Product ID	41250-971_e75c2a39-91ca-425d-8a2d-f7616394e02f
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	Meijer Distribution, 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 41250-0971-86 (41250097186)

Pricing Information	N/A
NDC Package Code	41250-971-86
Billing NDC	41250097186
Package	1000 mL in 1 BOTTLE, PLASTIC (41250-971-86)
Marketing Start Date	2013-02-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9a0b6301-2443-41f7-adeb-87578a65c26d Details

TEP

Sealed With Printed Neckband For Your Protection

Active ingredient

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

Purpose

Anticavity

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, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, blue 1

Disclaimer

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

Adverse reactions section

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.com

principal display panel

Compare to

Listerine Total Care Zero

active ingredients

meijer

Fresh Mint

Anticavity

Mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

Alcohol Free

6 Benefits:

Helps prevent cavities

Restores enamel

Strengthen teeth

Kills bad breath germs

Cleans the entire mouth

Freshens breath

IMPORTANT:

Read directions for proper use.

33.8 FL OZ (1 L)

INGREDIENTS AND APPEARANCE

ANTICAVITY

sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-971
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)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
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:41250-971-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/11/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/11/2013

Labeler - Meijer Distribution, Inc (006959555)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41250-971)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41250-971)

Revised: 5/2022

Document Id: e75c2a39-91ca-425d-8a2d-f7616394e02f

Set id: 9a0b6301-2443-41f7-adeb-87578a65c26d

Version: 11

Effective Time: 20220517