CHEWPASTE WITH FLUORIDE- sodium fluoride tablet, chewable

Chewpaste with Fluoride by

Drug Labeling and Warnings

Chewpaste with Fluoride by is a Otc medication manufactured, distributed, or labeled by 2557807 Ontario Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS:

0.25% Sodium fluoride (1.2mg)/tablet

PURPOSE:

Dentifrice

USES:

Helps prevent tooth decay

DIRECTIONS:

Adults and children over 6 years of age: 1 tablet, 2 times per day Do not swallow Pop 1 tablet in your mouth and chew, wet your toothbrush and brush normally Repeat every morning and night Consult a healthcare professional before using on children under 6 years

STORAGE:

Store in a tightly closed container in a cool, dry place

NON ACTIVE INGREDIENTS:

Dicalcium phosphate, Kaolin, Xylitol, Erythritol, Magnesium stearate, Sodium lauryl sulfoacetate, Sodium bicarbonate, Mint flavour, Hydroxypropyl methylcellulose, Clay, Vanilla flavour, Eucalyptol, Xanthan gum, Citric acid, Menthol

WARNING:

If swallowed, call a poison control centre or get medical help right away

Keep out of reach of children

SPL UNCLASSIFIED SECTION

Minty Vanilla

Do not use if seal is broken

Made in Canada

Etee Reusables Toronto, ON, Canada, shopetee.com

Packaging

INGREDIENTS AND APPEARANCE

CHEWPASTE WITH FLUORIDE 
sodium fluoride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81048-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.2 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
KAOLIN (UNII: 24H4NWX5CO)
XYLITOL (UNII: VCQ006KQ1E)
ERYTHRITOL (UNII: RA96B954X6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MINT (UNII: FV98Z8GITP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
BENTONITE (UNII: A3N5ZCN45C)
VANILLA BEAN (UNII: Q74T35078H)
EUCALYPTOL (UNII: RV6J6604TK)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Product Characteristics
Color	brown (Beige)	Score	no score
Shape	ROUND	Size	8mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81048-008-64	64 in 1 JAR; Type 0: Not a Combination Product	02/15/2021
2	NDC: 81048-008-92	192 in 1 JAR; Type 0: Not a Combination Product	02/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/15/2021

Labeler - 2557807 Ontario Inc (204249259)