ACT Anticavity Fluoride Iced Berry

Manufacturer
Chattem, Inc.
Effective date
2020-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:18:42

Label at a glance#

ProductACT Anticavity Fluoride Iced Berry
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

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 into cap (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 not swallow the rinse ■ do not eat or drink for 30 minutes after rinsing ■ instruct children under 12 years ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ACT

Anticavity Fluoride Mouthwash Iced Berry

Drug Facts

Purpose

OTC - PURPOSE SECTION

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

Use

INDICATIONS & USAGE SECTION

■ aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 into cap (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 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

SPL UNCLASSIFIED SECTION

■ do not use if safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, xylitol, propylene glycol, poloxamer 407, tetrasodium pyrophosphate, sodium lauroyl sarcosinate, sodium laurate, PEG-35 castor oil, sucralose, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, dipotassium glycyrrhizate

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACT
1 X Daily
ANTICAVITY
Fluoride Mouthwash
Iced Berry
18 fl oz (532 mL)

PRINCIPAL DISPLAY PANEL ACT 1 X Daily ANTICAVITY Fluoride Mouthwash Iced Berry 18 fl oz (532 mL)PRINCIPAL DISPLAY PANEL ACT 1 X Daily ANTICAVITY Fluoride Mouthwash Iced Berry 18 fl oz (532 mL) PRINCIPAL DISPLAY PANEL ACT 1 X Daily ANTICAVITY Fluoride Mouthwash Iced Berry 18 fl oz (532 mL)PRINCIPAL DISPLAY PANEL ACT 1 X Daily ANTICAVITY Fluoride Mouthwash Iced Berry 18 fl oz (532 mL)

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix0170170-01act-anticavity-fluoride-mouthwash-iced-berry-01.jpg
Data codeData Matrix0170171-01act-anticavity-fluoride-mouthwash-iced-berry-02.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-094741167-0947-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4104dd1a-5364-4cfb-b9a5-469d68291d2f4e048e89-e8bb-4f8b-8d69-dfbf0e57d7132023-01-04WarningsExact identifier
spl set id: 4e048e89-e8bb-4f8b-8d69-dfbf0e57d713

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.