KAYLAAN- zero waste refill for toothpaste tablet, chewable

KAYLAAN by

Drug Labeling and Warnings

KAYLAAN by is a Otc medication manufactured, distributed, or labeled by Kaylaan LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

PURPOSE

ACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KAYLAAN 
zero waste refill for toothpaste tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82091-113
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.37 mg  in 440 mg

Inactive Ingredients
Ingredient Name	Strength
STEVIA LEAF (UNII: 6TC6NN0876)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
XANTHAN GUM (UNII: TTV12P4NEE)
CALCIUM CARBONATE (UNII: H0G9379FGK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STRAWBERRY (UNII: 4J2TY8Y81V)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	5mm
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82091-113-01	74.3 mg in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	09/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2021

Labeler - Kaylaan LLC (077425217)

Establishment
Name	Address	ID/FEI	Business Operations
Kaylaan LLC		077425217	manufacture(82091-113)