BYHUMANKIND-Brand Packaging: Kindfill Mint

Kindfill by

Drug Labeling and Warnings

Kindfill by is a Otc medication manufactured, distributed, or labeled by By Humankind Inc, Brand Packaging Group Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KINDFILL- mint toothpaste tablets tablet, chewable 
By Humankind Inc

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.

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BYHUMANKIND-Brand Packaging: Kindfill Mint

Active Ingredient(s)

Sodium Fluoride .62mg (28 mg flouride ion)

Purpose

Anti-cavity

Use

aids in the prevention of dental cavities

Warnings

• When using this product, if irritation or sensitivity occurs discontinue use.
• Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

When using this product, if irritation or sensitivity occurs discontinue use.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 6 years of age and older; chew one tablet until crushed, wet toothbrush, brush for 2 minutes. Spit out.
• Do not swallow the tablet.
• Children under 6 years of age should be supervised when using this product.

Other information

Store at 25-30°C (68-77°F). Protect from excessive moisture.

Inactive ingredients

Microcrystalline Cellulose, Sodium bicarbonate (Baking Soda), Silica, Sodium Lauryl Glutamate, Magnesium Stearate, Natural Mint Flavor, Menthol, Xanthan Gum, Stevia (Stevioside), Citric Acid

Package Label - Principal Display Panel

60 in Each Box NDC: 82963-122-11

KINDFILL 
mint toothpaste tablets tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80487-122(NDC: 68984-111)
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.62 mg  in 312 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEVIA LEAF (UNII: 6TC6NN0876)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MINT (UNII: FV98Z8GITP)
MENTHOL, (+)- (UNII: C6B1OE8P3W)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor	PEPPERMINT	Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80487-122-11	60 in 1 BOX	09/07/2022
1		312 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/07/2022	08/31/2023

Labeler - By Humankind Inc (117642980)

Establishment
Name	Address	ID/FEI	Business Operations
Brand Packaging Group Inc		808875541	repack(80487-122)

Revised: 12/2022

Document Id: f0334831-0a76-d6ef-e053-2995a90a0eb9

34390-5

Set id: e8ab4c3d-103a-5296-e053-2a95a90a3322

Version: 2

Effective Time: 20221219