THE HUMBLECO NATURAL FRESH MINT- sodium fluoride paste, dentifrice 
The Humble Company USA, 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 HumbleCo. Natural Toothpaste Fresh Mint

Drug Facts

Active ingredient

Sodium fluoride 0.237%

Purpose

anticavity

Use/Indication

aids in the prevention of dental cavities

Warnings

When using this product

if irriation occurs discontinue use.

Keep out of reach of children

under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contat a Poision Control Center right away.

Directions

> adults and children 2 years of age and older:
- apply toothpaste onto a toothbrush
- brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age 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 O C (77 OF)

Contact/Questions:

Call 1 (858) 876-5174

Inactive ingredients

HYDROGENATED STARCH HYDROLYSATE, AQUA, HYDRATED SILICA, LAURYL GLUCOSIDE, XANTHAN GUM, MENTHA PIPERITA OIL, SODIUM FLUORIDE, ZINC GLUCONATE, MENTHOL, STEVIA REBAUDIANA EXTRACT, ALOE BARBADENSIS LEAF JUICE POWDER, SALVIA TRILOBA LEAF EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, COMMIPHORA MYRRHA RESIN EXTRACT, LIMONENE, CI 77891.

Package Labeling:

Label2

THE HUMBLECO NATURAL FRESH MINT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72299-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
MENTHOL (UNII: L7T10EIP3A)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
THREE-LOBE SAGE (UNII: 3V97D33N0K)  
MYRRH (UNII: JC71GJ1F3L)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72299-001-0075 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2018
Labeler - The Humble Company USA, Inc (080780354)

Revised: 5/2018
Document Id: 6d59d405-79d4-230f-e053-2a91aa0a3472
Set id: 6d59d405-79d3-230f-e053-2a91aa0a3472
Version: 1
Effective Time: 20180529
 
The Humble Company USA, Inc