GEL 1100 MINT- sodium fluoride gel, dentifrice 
GEL 1100 CITRUS- sodium fluoride gel, dentifrice 
GEL 1100 GRAPE- sodium fluoride gel, dentifrice 
Dental Alliance Holdings LLC

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Gel 1100

Active Ingredients

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

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

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

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

Tube Principle Display Panel

CARIFREE®

Gel 1100

Anti-Cavity Toothpaste

Mint

2.4oz (68g)

​Active ingredients

Sodium Fluoride 0.24%

​Purpose​ Anticavity

Use

​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

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 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

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

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

Sample 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

Tube Principle Display Panel

CARIFREE®

Gel 1100

Anti-Cavity Toothpaste

Mint

2.4oz (68g)

​Active ingredients

Sodium Fluoride 0.24%

​Purpose​ Anticavity

Use

​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

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 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

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

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

Tube Principle Display Panel

CARIFREE®

Gel 1100

Anti-Cavity Toothpaste

Grape

2.4oz (68g)

​Active ingredients

Sodium Fluoride 0.24%

​Purpose​ Anticavity

Use

​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

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 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

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

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

GEL 1100  MINT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-213
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1100 ug  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MENTHA SPICATA OIL (UNII: C3M81465G5)  
HYDROXYAPATITE (UNII: 91D9GV0Z28)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61578-213-0168 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product05/10/2022
2NDC:61578-213-0224.1 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product11/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02105/10/2022
GEL 1100  CITRUS
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-214
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1100 ug  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYDROXYAPATITE (UNII: 91D9GV0Z28)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorCITRUSImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61578-214-0168 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02105/10/2022
GEL 1100  GRAPE
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-217
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1100 ug  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYDROXYAPATITE (UNII: 91D9GV0Z28)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61578-217-0168 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02105/10/2022
Labeler - Dental Alliance Holdings LLC (195544965)
Registrant - Dental Alliance Holdings LLC (195544965)
Establishment
NameAddressID/FEIBusiness Operations
Dental Alliance Holdings LLC195544965manufacture(61578-213, 61578-214, 61578-217)

Revised: 12/2025
Document Id: 8c79367f-d60d-484b-8e32-87de7cf75358
Set id: f125fb04-5045-5367-e053-2a95a90aa73b
Version: 3
Effective Time: 20251229
 
Dental Alliance Holdings LLC