ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Liberty Procurement, Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anticavity Rinse aids in the prevention of dental cavities
Authorization status:
OTC monograph final
Authorization number:
63940-213-44

ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

Liberty Procurement, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Core Values 213.002/213AE rev 2

Active ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpos e

Anticavity Rinse

Us e

aids in the prevention of dental cavities

Warning

for this product only

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a

Poison Control Center immediately.

Directions

adults and children 6 years of age and older: use once a day after brushing your teeth with a

toothpaste.

remove cap

pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark

vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out

do now 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 necessay until capable of using without supervision

children under 6 years of age: consult a dentist or doctor

other information

store at room temperature

inactive ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin,

poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium

disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3,

yellow 5

ADA Council Statement

"The ADA Council on Scientific Affairs Acceptance of Core Values Mint Anticavity Fluoride Rinse is

based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used

as directed."

Dis claimer

This product is not manufactured or distributed by Chattem, Inc., distributor of Act

Adverse reactions

Distributed by

Liberty Procurement, Inc

650 Liberty Ave.

Union, NJ 07083 USA

Visit us at: 222.facevalues.com

SATISFACTION GUARANTEED

Or Your

Money Back

213.002/213AE Rev 2

principal display panel

Sealed with printed neckband for your protection.

COREVALUES

Compare to the active ingredients in ACT

Anticavity

FLUORIDE

RINSE

Helps prevent cavies

Helps strengthen teeth

Freshens breath

Mint Flavor

Accepted

American

Dental

Asociation

IMPORTANT: Read directions for proper use.

18 FL OZ (1 PT 2 FL OZ) 532 mL

ANTICAVITY FLUORIDE RINSE

sodium fluoride mouthwash

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 40 -213

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

0 .2 mg in 1 mL

Liberty Procurement, Inc

Inactive Ingredients

Ingredient Name

Stre ng th

wa ter (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

MENTHO L (UNII: L7T10 EIP3A)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM PHO SPHATE (UNII: SE337SVY37)

SO DIUM PHO SPHATE, DIBASIC, MO NO HYDRATE (UNII: BWZ7K44R51)

EDETATE CALCIUM DISO DIUM ANHYDRO US (UNII: 8 U5D0 349 55)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 39 40 -213-

532 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/0 6 /20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 7/0 6 /20 16

Labeler -

Liberty Procurement, Inc (804085293)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

79 0 752542

ma nufa c ture (6 39 40 -213)

Revised: 5/2020

Similar products

Search alerts related to this product

View documents history

Share this information