The Humble Co. Fresh Mint Toothpaste

The Humble Co. Fresh Mint by

Drug Labeling and Warnings

The Humble Co. Fresh Mint by is a Otc medication manufactured, distributed, or labeled by The Humble Company North America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THE HUMBLE CO. FRESH MINT- sodium fluoride paste, dentifrice 
The Humble Company North America, 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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The Humble Co. Fresh Mint Toothpaste

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.14% w/v fluoride ion)

Purpose

Anticavity Toothpaste

Use

aids in the prevention of dental cavities

Warning

Keep out of reach of children under 6 years of age.

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

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
• Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.

Other information

store below 25°C (77°F)

Inactive ingredients

sorbitol, water, hydrated silica, lauryl glucoside, xanthan gum, titanium dioxide, zinc gluconate, peppermint oil, menthol, stevia rebaudiana extract, aloe vera leaf juice powder, three-lobe sage leaf extract, chamomile flower extract, myrrh resin extract, limonene

Questions?

Call 1(858) 876-5174

Package Labeling:

THE HUMBLE CO. FRESH MINT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72299-014
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
PEPPERMINT OIL (UNII: AV092KU4JH)
MENTHOL (UNII: L7T10EIP3A)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
THREE-LOBE SAGE (UNII: 3V97D33N0K)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72299-014-03	97 g in 1 TUBE; Type 0: Not a Combination Product	12/24/2020	12/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/24/2020	12/20/2021

Labeler - The Humble Company North America, Inc (010966342)

Revised: 12/2021

Document Id: d3ae26ab-c0ba-7cde-e053-2a95a90a8e4c

34390-5

Set id: b79fd142-e926-0f65-e053-2995a90ac060

Version: 2

Effective Time: 20211221