Label: GEL 1100 MINT- sodium fluoride gel, dentifrice
GEL 1100 CITRUS- sodium fluoride gel, dentifrice
GEL 1100 GRAPE- sodium fluoride gel, dentifrice
- NDC Code(s): 61578-213-01, 61578-213-02, 61578-214-01, 61578-217-01
- Packager: Dental Alliance Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 29, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warning
- Keep out of reach of children under 6 years of age.
-
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 (Mint only), Flavor (Citrus and Grape only), Hydroxyapatite, Polysorbate 20, Menthol (Mint only), Sodium Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide
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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 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
-
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 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
-
INGREDIENTS AND APPEARANCE
GEL 1100 MINT
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61578-213 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1100 ug in 1 g Inactive Ingredients Ingredient Name Strength 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 Color white (opaque) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61578-213-01 68 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 05/10/2022 2 NDC:61578-213-02 24.1 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 11/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 05/10/2022 GEL 1100 CITRUS
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61578-214 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1100 ug in 1 g Inactive Ingredients Ingredient Name Strength 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 Color white (opaque) Score Shape Size Flavor CITRUS Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61578-214-01 68 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 05/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 05/10/2022 GEL 1100 GRAPE
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61578-217 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1100 ug in 1 g Inactive Ingredients Ingredient Name Strength 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 Color white (opaque) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61578-217-01 68 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 05/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 05/10/2022 Labeler - Dental Alliance Holdings LLC (195544965) Registrant - Dental Alliance Holdings LLC (195544965) Establishment Name Address ID/FEI Business Operations Dental Alliance Holdings LLC 195544965 manufacture(61578-213, 61578-214, 61578-217)