ACT Braces Care Anticavity

Manufacturer
Chattem, Inc.
Effective date
2023-10-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:23:58

Label at a glance#

ProductACT Braces Care Anticavity
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

adults and children 6 years of age and older: use twice 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 the 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

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 twice 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 the 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, poloxamer 407, propylene glycol, aloe barbadensis leaf juice powder, tetrasodium pyrophosphate, sodium lauroyl sarcosinate, sodium laurate, glycerin, menthol, menthyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, benzyl alcohol, sodium benzoate, green 3, red 33 (309-092)

Learn more at ACTBRACESCARE.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
FLUORIDE BRAND

NEW!

ACT BRACES CARE
Anitcavity Fluoride Mouthwash
Clean Mint

18 fl oz. (532
 mL)

PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND NEW! ACT BRACES CARE Anitcavity Fluoride Mouthwash Clean Mint 18 fl oz. (532 mL)PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND NEW! ACT BRACES CARE Anitcavity Fluoride Mouthwash Clean Mint 18 fl oz. (532 mL)PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND NEW! ACT BRACES CARE Anitcavity Fluoride Mouthwash Clean Mint 18 fl oz. (532 mL)PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND NEW! ACT BRACES CARE Anitcavity Fluoride Mouthwash Clean Mint 18 fl oz. (532 mL)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W74
FLUORIDE IONACTIVE MOIETYQ80VPU408O4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH4
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49P4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L4
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D0349554
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1S4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3A4
MENTHYL SALICYLATE, (+/-)-INACTIVE INGREDIENT43XOA705ZD4
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M24
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH4
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ44
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU4
SODIUM LAURATEINACTIVE INGREDIENTK146MR5EXO4
SODIUM LAUROYL SARCOSINATEINACTIVE INGREDIENT632GS996184
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY374
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6F4
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8Z4
SORBITOLINACTIVE INGREDIENT506T60A25R4
WATERINACTIVE INGREDIENT059QF0KO0R4
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E4

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-095241167-0952-3, 41167-0952-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 531 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37SOLUTION / NASAL1.89 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37CONCENTRATE / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRAVESICAL38.25 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY, METERED / NASAL7 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37CREAM / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2GEL / TOPICAL28 mgExact identifier — unii candidate
15 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION / ORAL0.13 mg/5mlExact identifier — unii candidate
14 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM, SOLUBLE / ORAL0.05 mgExact identifier — unii candidate
48 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTAMPON / VAGINAL64.8 mgExact identifier — unii candidate
28 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SSOLUTION / ORAL0.25 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRALESIONAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37MOUTHWASH / BUCCALNAExact identifier — unii candidate
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, EXTENDED RELEASE / ORAL207 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM LAUROYL SARCOSINATESODIUM LAUROYL SARCOSINATE632GS99618LOTION / TOPICAL70 mgExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SGEL / DENTALNAExact identifier — unii candidate
15 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION / INTRADERMAL0.2 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii candidate
19 equally ranked IID candidates

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
0e171c5a-9fa1-4041-a555-1b22431d0ff6e3494d8a-2aad-4212-89ce-18dddcbe059e2024-02-19WarningsExact identifier
spl set id: e3494d8a-2aad-4212-89ce-18dddcbe059e

Reported adverse events (FAERS/openFDA)#

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