ACT ANTICAVITY FLUORIDE MINT- sodium fluoride rinse

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

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Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Chattem, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anticavity - aids in the prevention of dental cavities
Authorization status:
OTC monograph final
Authorization number:
41167-0942-1, 41167-0942-3, 41167-0942-8

ACT ANTICAVITY FLUORIDE MINT- sodium fluoride rinse

Chattem, 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.

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ACT Anticavity Fluoride Rinse Mint

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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 once a day after brushing your teeth with a toothpaste

remove cap

hold bottle upright and squeeze. Fill to FILL LINE

pour out. Only the correct 10 milliliters dose will pour out.

vigorously swish 10 milliliters 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

Other information

contains FD&C yellow no. 5 (tartrazine) as a color additive

do not use if safety seal is broken or missing

Inactive ingredients

water, sorbitol, poloxamer 407, propylene glycol, menthol, methyl salicylate, sodium phosphate,

potassium sorbate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, calcium disodium

EDTA, sodium benzoate, green 3, yellow 5 (309-039)

Learn more at www.ACTFLUORIDE.com

PRINCIPAL DISPLAY PANEL

ZERO ALCOHOL

# 1 DENTIST RECOMMENDED

FLUORIDE BRAND

ACT

1X Daily

ANTICAVITY

FLUORIDE MOUTHWASH

MINT

18 fl oz (532 mL)

ACT ANTICAVITY FLUORIDE MINT

sodium fluoride rinse

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4116 7-0 9 42

Route of Administration

TOPICAL

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

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

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

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

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

MENTHO L (UNII: L7T10 EIP3A)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

SO DIUM PHO SPHATE (UNII: SE337SVY37)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P)

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

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

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

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

Product Characteristics

Color

GREEN

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:4116 7-

0 9 42-1

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

Pro duc t

0 4/0 1/19 9 4

2

NDC:4116 7-

0 9 42-3

8 8 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/0 1/19 9 4

0 3/15/20 11

3

NDC:4116 7-

0 9 42-8

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

Pro duc t

0 4/0 1/19 9 4

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt355

0 4/0 1/19 9 4

Chattem, Inc.

Labeler -

Chattem, Inc. (003336013)

Revised: 4/2019

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