TREATMENT RINSE APPLE- anticaries rinse TREATMENT RINSE MINT- anticaries rinse

Treatment Rinse by

Drug Labeling and Warnings

Treatment Rinse 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 0.05% when mixed with part B

Purpose:

Anticavity

Use:

Aids in the prevention of dental caries (cavities)

Warnings:

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If you experience any unusual symptoms, stop use and contact your dentist.

Warnings:

Keep out of reach of children.

Directions:

Do not use before mixing with Part B. Adults and children 6 years of age and older: Use once daily after brushing. Shake each bottle before use. Using the measuring cup, combine 5 mL of component A with 5 mL of component B (10 mL, total). Vigorously swish the combined 10 mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or physician. Do not dilute. Do not use either component alone. Store below 30 degrees C (86 degrees F). Do not freeze.

Inactive ingredients:

Menthol, Natural Flavors, Polysorbate 20, Sodium Benzoate, Sodium Hydroxide, Sodium Hypochlorite, Water, Xylitol.

Treatment Rinse Mint and Apple enclosure and carton labels:

INGREDIENTS AND APPEARANCE

TREATMENT RINSE  APPLE
anticaries rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61578-315
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	226 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Product Characteristics
Color	white (hazy)	Score
Shape		Size
Flavor	APPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61578-315-01	2 in 1 PACKAGE	05/10/2022
1		175.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/10/2022

TREATMENT RINSE  MINT
anticaries rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61578-314
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	226 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Product Characteristics
Color	white (hazy)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61578-314-01	2 in 1 PACKAGE	05/10/2022
1		175.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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(61578-314, 61578-315)