HEY HUMANS WHITENING CLEAN MINT RUSH- sodium fluoride paste, dentifrice 
Maesa LLC

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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Hey Humans Whitening Clean Mint Rush

Drug Facts

Active Ingredients

Sodium Fluoride 0.25% (0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

Warnings

  • 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

Inactive Ingredients

Glycerin, Sorbitol, Hydrated Silica, Water, Xylitol, Cocamidopropyl Betaine, Flavor, Sodium Cocoyl Glutamate, Xanthan Gum, Stevia Rebaudiana Leaf/Stem Extract, Cellulose Gum, Menthol, Squalene.

Questions or Comments

You may report an adverse reaction to: HEY HUMANS c/o Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.

DISTRIBUTED BY: MAESA LLC
225 LIBERTY STREET,
NEW YORK, NY 10281.

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

Naturally Derived
Toothpaste

With Fluoride

Hey
Humans

With Everice™
Technology

WHITENING

Long-lasting fresh breath,
anticavity, anti-plaque,
anti-tartar

Clean Mint
Rush

Artificial sweetener,
phthalate, paraben
& sulfate free

NET WT. 96 g / 3.4 OZ.

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
HEY HUMANS WHITENING CLEAN MINT RUSH 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71899-200
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Water (UNII: 059QF0KO0R)  
Xylitol (UNII: VCQ006KQ1E)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG)  
Xanthan Gum (UNII: TTV12P4NEE)  
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Squalene (UNII: 7QWM220FJH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71899-200-011 in 1 CARTON01/31/2021
196 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/31/2021
Labeler - Maesa LLC (144282311)
Establishment
NameAddressID/FEIBusiness Operations
Nutrix International LLC117341868MANUFACTURE(71899-200)

Revised: 3/2021
Document Id: 2dd09626-6704-4128-9089-3f1f82261bb3
Set id: 79137d9a-db85-4e65-9490-a1d13510ab80
Version: 1
Effective Time: 20210301
 
Maesa LLC