GEL 1100 MINT- sodium fluoride gel, dentifrice GEL 1100 CITRUS- sodium fluoride gel, dentifrice GEL 1100 GRAPE- sodium fluoride gel, dentifrice

Gel 1100 by

Drug Labeling and Warnings

Gel 1100 by is a Otc medication manufactured, distributed, or labeled by Dental Alliance Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients:

Sodium Fluoride 0.24%

Purpose:

Anticavity

Use:

Aids in the prevention of dental caries (cavities)

Warnings:

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.

Warnings:

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:

Glycerin, Hydrated Silica, Hydrogenated Starch Hydrolysate (HSH), Hydroxyapatite, Hydroxyethyl Cellulose, Menthol (Mint only), Natural Flavors, Artificial Flavors (Citrus and Grape only) Polysorbate 20, Potassium Sorbate, Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water, Xylitol

Gel 1100 Mint, Citrus, and Grape enclosure and carton labels

INGREDIENTS AND APPEARANCE

GEL 1100  MINT
sodium fluoride gel, dentifrice

Product 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
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MALTITOL (UNII: D65DG142WK)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)
MENTHOL (UNII: L7T10EIP3A)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN (UNII: FST467XS7D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

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

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, dentifrice

Product 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
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MALTITOL (UNII: D65DG142WK)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN (UNII: FST467XS7D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

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, dentifrice

Product 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
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MALTITOL (UNII: D65DG142WK)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN (UNII: FST467XS7D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

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(61578-214, 61578-217, 61578-213)