Gel 1100

Manufacturer
Dental Alliance Holdings LLC
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:32

Label at a glance#

ProductGel 1100 Mint
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (0.13% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental caries (cavities).

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing 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: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Xylitol, Hydrated Silica, Glycerin, Hydrogenated Starch Hydrolysate, Hydroxyethyl Cellulose, Sodium Lauryl Sulfate, Potassium Sorbate, Mentha Spicata (Spearmint) Leaf Oil (Mint only), Flavor (Citrus and Grape only), Hydroxyapatite, Polysorbate 20, Menthol (Mint only), Sodium Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide

CARIFREE Gel 1100 Anti-Cavity Toothpaste Mint 68 g - NDC 61578-213-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Principle Display PanelTube Principle Display Panel

CARIFREE®

Gel 1100

Anti-Cavity Toothpaste

Mint

2.4oz (68g)

​Active ingredients

Sodium Fluoride 0.24%

​Purpose​ Anticavity

​Use

  • Aids in the prevention of dental caries (cavities).

​​Warning: Keep out of reach of children under 6 years of age.​​ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

​Directions

  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

pH+® HAITM NANO

U.S. PATENTS NO. 9,427,384 and 10,143,633

Questions or comments?

(800) 503-0625 or visit CariFree.com

CariFree and pH+ are registered trademarks of Oral BioTech.

Manufactured by Oral BioTech

Albany, Oregon 97321

Box Principle Display PanelBox Principle Display Panel

CARIFREE®

Gel 1100

Fluoride Anti-Cavity Toothpaste

Mint

NET WT 2.4 OZ (68 g)

​Drug Facts

Active ingredients

Sodium Fluoride 0.24%

Purpose Anticavity

Use

  • Aids in the prevention of dental caries (cavities).

Warning: Keep out of reach of children under 6 years of age

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

Directions

  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

Water, Xylitol, Hydrated Silica, Glycerin, Hydrogenated Starch Hydrolysate, Hydroxyethyl Cellulose, Sodium Lauryl Sulfate, Potassium Sorbate, Mentha Spicata (Spearmint) Leaf Oil, Hydroxyapatite, Polysorbate 20, Menthol, Sodium Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide

CARIFREE®

Questions or comments?

(800) 503-0625 or visit CariFree.com

CariFree and pH+ are registered trademarks of Oral BioTech.

Manufactured by Oral BioTech

Albany, Oregon 97321

Prevents Cavities

with .24% Sodium Fluoride

Low Abrasion Formula

Elevated pH

25% Xylitol

pH+®

nanoXIM Medical

CariFree and pH+ are registered trademarks of Oral BioTech.

U.S. PATENTS NO. 9,427,384 and 10,143,63

CARIFREE Gel 1100 Anti-Cavity Toothpaste Mint 24.1 g - NDC 61578-213-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sample Principle Display PanelSample Principle Display Panel

CARIFREE®

Gel 1100

Fluoride Anti-Cavity Toothpaste

Mint

NET WT .85 OZ (24.1 g)

​Active ingredients​Purpose
Sodium Fluoride 0.24% (0.13 % w/v fluoride ion)Anticavity

Use Aids in the prevention of dental caries (cavities).

Warning: Keep out of reach of children under 6 years of age If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. • Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. • Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients Water, Xylitol, Hydrated Silica, Glycerin, Hydrogenated Starch Hydrolysate, Hydroxyethyl Cellulose, Sodium Lauryl Sulfate, Potassium Sorbate, Mentha Spicata (Spearmint) Leaf Oil, Hydroxyapatite, Polysorbate 20, Menthol, Sodium Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide

Manufactured by Oral BioTech

Albany, Oregon 97321

(800) 503-0625 • CariFree.com

CARIFREE Gel 1100 Anti-Cavity Toothpaste Citrus 68 g - NDC 61578-214-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Principle Display PanelTube Principle Display Panel

CARIFREE®

Gel 1100

Anti-Cavity Toothpaste

Mint

2.4oz (68g)

​Active ingredients

Sodium Fluoride 0.24%

​Purpose​ Anticavity

​Use

  • Aids in the prevention of dental caries (cavities).

​​Warning: Keep out of reach of children under 6 years of age.​​ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

​Directions

  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

pH+® HAITM NANO

U.S. PATENTS NO. 9,427,384 and 10,143,633

Questions or comments?

(800) 503-0625 or visit CariFree.com

CariFree and pH+ are registered trademarks of Oral BioTech.

Manufactured by Oral BioTech

Albany, Oregon 97321

Box Principle Display PanelBox Principle Display Panel

CARIFREE®

Gel 1100

Fluoride Anti-Cavity Toothpaste

Mint

NET WT 2.4 OZ (68 g)

​Drug Facts

Active ingredients

Sodium Fluoride 0.24%

Purpose Anticavity

Use

  • Aids in the prevention of dental caries (cavities).

Warning: Keep out of reach of children under 6 years of age

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

Directions

  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

Water, Xylitol, Hydrated Silica, Glycerin, Hydrogenated Starch Hydrolysate, Flavor, Hydroxyethyl Cellulose, Sodium Lauryl Sulfate, Potassium Sorbate, Hydroxyapatite, Polysorbate 20, Sodium Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide

CARIFREE®

Questions or comments?

(800) 503-0625 or visit CariFree.com

CariFree and pH+ are registered trademarks of Oral BioTech.

Manufactured by Oral BioTech

Albany, Oregon 97321

Prevents Cavities

with .24% Sodium Fluoride

Low Abrasion Formula

Elevated pH

25% Xylitol

pH+®

nanoXIM Medical

CariFree and pH+ are registered trademarks of Oral BioTech.

U.S. PATENTS NO. 9,427,384 and 10,143,63

CARIFREE Gel 1100 Anti-Cavity Toothpaste Grape 68 g - NDC 61578-217-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Principle Display PanelTube Principle Display Panel

CARIFREE®

Gel 1100

Anti-Cavity Toothpaste

Grape

2.4oz (68g)

​Active ingredients

Sodium Fluoride 0.24%

​Purpose​ Anticavity

​Use

  • Aids in the prevention of dental caries (cavities).

​​Warning: Keep out of reach of children under 6 years of age.​​ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

​Directions

  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

pH+® HAITM NANO

U.S. PATENTS NO. 9,427,384 and 10,143,633

Questions or comments?

(800) 503-0625 or visit CariFree.com

CariFree and pH+ are registered trademarks of Oral BioTech.

Manufactured by Oral BioTech

Albany, Oregon 97321

Box Principle Display PanelBox Principle Display Panel

CARIFREE®

Gel 1100

Fluoride Anti-Cavity Toothpaste

Grape

NET WT 2.4 OZ (68 g)

​Drug Facts

Active ingredients

Sodium Fluoride 0.24%

Purpose Anticavity

Use

  • Aids in the prevention of dental caries (cavities).

Warning: Keep out of reach of children under 6 years of age

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

Directions

  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

Water, Xylitol, Hydrated Silica, Glycerin, Hydrogenated Starch Hydrolysate, Hydroxyethyl Cellulose, Sodium Lauryl Sulfate, Potassium Sorbate, Flavor, Hydroxyapatite, Polysorbate 20, Sodium Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide

CARIFREE®

Questions or comments?

(800) 503-0625 or visit CariFree.com

CariFree and pH+ are registered trademarks of Oral BioTech.

Manufactured by Oral BioTech

Albany, Oregon 97321

Prevents Cavities

with .24% Sodium Fluoride

Low Abrasion Formula

Elevated pH

25% Xylitol

pH+®

nanoXIM Medical

CariFree and pH+ are registered trademarks of Oral BioTech.

U.S. PATENTS NO. 9,427,384 and 10,143,63

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61578-213-01Gel 1100Mint68 g in 1 TUBE, WITH APPLICATORGEL, DENTIFRICE683
61578-213-02Gel 1100Mint24.1 g in 1 TUBE, WITH APPLICATORGEL, DENTIFRICE24.13
61578-214-01Gel 1100Citrus68 g in 1 TUBE, WITH APPLICATORGEL, DENTIFRICE683
61578-217-01Gel 1100Grape68 g in 1 TUBE, WITH APPLICATORGEL, DENTIFRICE683

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
61578-21361578-213-01, 61578-213-02
61578-21461578-214-01
61578-21761578-217-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 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
Gel 1100 MintSODIUM FLUORIDEDental Alliance Holdings LLCf125fb04-5045-5367-e053-2a95a90aa73b2025-12-29WarningsExact identifier
ndc (package): 61578-214-01
ndc (package): 61578-213-01
ndc (package): 61578-217-01
ndc (package): 61578-213-02
ndc (product): 61578-217
ndc (product): 61578-214
ndc (product): 61578-213
ndc11 (package): 61578021701
ndc11 (package): 61578021302
ndc11 (package): 61578021301
ndc11 (package): 61578021401
spl id: 8c79367f-d60d-484b-8e32-87de7cf75358
spl set id: f125fb04-5045-5367-e053-2a95a90aa73b

Reported adverse events (FAERS/openFDA)#

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