FDA.reportPublic FDA data

Kindfill

Manufacturer
By Humankind Inc | Make USA LLC | Denttabs GmbH
Effective date
2021-02-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:02

Key Label Information#

Active Ingredients And Purpose

Active Ingredient(s)

Sodium Fluoride .62mg (28 mg flouride ion)

Purpose

Anti-cavity

Uses

Use

aids in the prevention of dental cavities

Warnings

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.

Directions And Dosage

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 Label Information

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:80487-112-11

Label Images#

BYHUMAN
BYHUMAN

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80487-112-112025-11-01C16284748780-1e4f33bdf-abc3-d8a0-e053-dadaa90a6e4eBYHUMANKIND-MAKE USA: Kindfill Dental Tabs
80487-112-112022-07-29C16284748780-1e4f33bdf-abc3-d8a0-e053-dadaa90a6e4eBYHUMANKIND-MAKE USA: Kindfill Dental Tabs

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80487-112KINDFILL (MINT TOOTHPASTE TABLETS) TABLET, CHEWABLE [BY HUMANKIND INC]2Legacy NDC20210211_baeb873e-e8cc-22cb-e053-2995a90ae0a0.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80487-11280487-112-11

Ingredients#

Name, UNII, Kind table
NameUNIIKind
STEVIA LEAF6TC6NN0876IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINTFV98Z8GITPIACT
MENTHOL, (+)-C6B1OE8P3WIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM LAUROYL GLUTAMATENCX1UU2D33IACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

Complete SPL Sections#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride .62mg (28 mg flouride ion)

Purpose

OTC - PURPOSE SECTION

Anti-cavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

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.

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 in Each Box NDC:80487-112-11

Source Document#

Source XML