Gel 1100

Gel 1100
SPL v3
SPL
SPL Set ID f125fb04-5045-5367-e053-2a95a90aa73b
Route
DENTAL
Published
Effective Date 2025-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1100 ug)
Inactive Ingredients
Water Xylitol Hydrated Silica Glycerin Hydrogenated Starch Hydrolysate Hydroxyethyl Cellulose (3000 Cps At 1%) Sodium Lauryl Sulfate Potassium Sorbate Mentha Spicata Oil Hydroxyapatite Polysorbate 20 Menthol Sodium Saccharin Sodium Benzoate Sodium Bicarbonate Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-10
Description

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

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

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

Use

Aids in the prevention of dental caries (cavities).

Warning

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.
Active Ingredients

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

Inactive Ingredients

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

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.

Carifree Gel 1100 Anti Cavity Toothpaste Mint 68 G Ndc 61578 213 01

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

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 Grape 68 G Ndc 61578 217 01

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

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

Carifree Gel 1100 Anti Cavity Toothpaste Citrus 68 G Ndc 61578 214 01

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

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 Mint 24.1 G Ndc 61578 213 02

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

Structured Label Content

Use

Aids in the prevention of dental caries (cavities).

Purpose

Anticavity

Warning

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.
Active Ingredients

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

Inactive Ingredients

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

Keep Out of Reach of Children Under 6 Years of Age. (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.

Carifree Gel 1100 Anti Cavity Toothpaste Mint 68 G Ndc 61578 213 01 (CARIFREE Gel 1100 Anti-Cavity Toothpaste Mint 68 g - NDC 61578-213-01)

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

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 Grape 68 G Ndc 61578 217 01 (CARIFREE Gel 1100 Anti-Cavity Toothpaste Grape 68 g - NDC 61578-217-01)

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

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

Carifree Gel 1100 Anti Cavity Toothpaste Citrus 68 G Ndc 61578 214 01 (CARIFREE Gel 1100 Anti-Cavity Toothpaste Citrus 68 g - NDC 61578-214-01)

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

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 Mint 24.1 G Ndc 61578 213 02 (CARIFREE Gel 1100 Anti-Cavity Toothpaste Mint 24.1 g - NDC 61578-213-02)

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

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Source: dailymed · Ingested: 2026-02-15T12:07:58.179963 · Updated: 2026-03-14T23:12:02.945870