HEY HUMANS WHITENING WINTERMINT CHILL- sodium fluoride paste, dentifrice

Hey Humans Whitening Wintermint Chill by

Drug Labeling and Warnings

Hey Humans Whitening Wintermint Chill by is a Otc medication manufactured, distributed, or labeled by Maesa LLC, Nutrix International LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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

Purpose

Anticavity

Uses

• Helps protect against cavities.

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

• Adults and children 2 years and older:
  • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
• Children 2 to 6 years:
  • To minimize swallowing, use only a pea-sized amount.
  • Supervise children's brushing and rinsing until good habits are established.
• Children under 2 years of age: Consult a dentist or physician.

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.

SPL UNCLASSIFIED SECTION

DIST. BY MAESA LLC, NEW YORK, NY 10281

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

Naturally Derived
Toothpaste

With Fluoride

Hey
Humans

Everice™
Technology

WHITENING, ANTICAVITY,
ANTI-PLAQUE, ANTI-TARTAR

Wintermint
Chill

NET WT.
96 g / 3.4 OZ.

INGREDIENTS AND APPEARANCE

HEY HUMANS WHITENING WINTERMINT CHILL 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71899-201
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71899-201-01	1 in 1 CARTON	01/31/2021
1		96 g in 1 TUBE; 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	01/31/2021

Labeler - Maesa LLC (144282311)

Establishment
Name	Address	ID/FEI	Business Operations
Nutrix International LLC		117341868	MANUFACTURE(71899-201)