KAYLAAN: Package Insert and Label Information

KAYLAAN- sodium fluoride tablet, chewable
Kaylaan LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

WARNINGS SECTION
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INACTIVE INGREDIENT SECTION
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INDICATIONS & USAGE SECTION

OTC-KEEP OUT OF REACH OF CHILDREN SECTION
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OTC -- PURPOSE SECTION
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OTC-ACTIVE INGREDIENT SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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KAYLAAN
zero waste refill for toothpaste tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82091-114
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.37 mg in 440 mg
Inactive Ingredients
Ingredient Name Strength
STEVIA LEAF
CALCIUM CARBONATE
BLUEBERRY
ERYTHRITOL
XYLITOL
MAGNESIUM STEARATE
SODIUM BICARBONATE
SODIUM COCOYL ISETHIONATE
XANTHAN GUM
Product Characteristics
Color blue Score no score
Shape ROUND Size 5mm
Flavor BLUEBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82091-114-01 74.3 mg in 1 BOX, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 09/13/2021
Labeler — Kaylaan LLC (077425217)
Establishment
Name Address ID/FEI Operations
Kaylaan LLC 077425217 manufacture (82091-114)

Revised: 09/2021 Kaylaan LLC

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