MAESA - HEY HUMAN- clean mint rush paste, dentifrice

Maesa - Hey Human by

Drug Labeling and Warnings

Maesa - Hey Human by is a Otc medication manufactured, distributed, or labeled by Nutrix International, LLC., Nutrix international, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium fluoride 0.25%

(0.15%w/v fluoride ion)

Purpose

Anticavity

Use

Helps protect against cavitities

Warnings

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

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

KEEP OUT OF REACH OF CHILDREN

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 doctor.

Children 2 to 6 years:

To minimize swallowing, use only a pea-size amount.

Supervise Children's brushing and rinsing until good habits are stablished.

Children under 2 years of age:

Consult a dentist or physician

Inactive Ingredients

Glycerin, water, Hydrate Silica, Sorbitol, Xylitol, Cocomidopropyl Betaine, Flavor, Xanthan Gum, Stevia Rebaudiana leaf/steam extract, Cellulose gum, Sodium cocoyl Glutamate, Menthol and Squalane.

Questions or Comments

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

For more Information, please visit www.heyhumans.com

Package, Label

Display Panel

INGREDIENTS AND APPEARANCE

MAESA - HEY HUMAN 
clean mint rush paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73333-200
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.25 g  in 96 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.2801 g  in 96 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	0.01678 g  in 96 g
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)	0.0016 g  in 96 g
SORBITOL (UNII: 506T60A25R)	0.25 g  in 96 g
WATER (UNII: 059QF0KO0R)	0.1474 g  in 96 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.18 g  in 96 g
XYLITOL (UNII: VCQ006KQ1E)	0.1 g  in 96 g
TETRAGONIA TETRAGONIOIDES WHOLE (UNII: 414NLG6K5S)	0.008 g  in 96 g
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)	0.005 g  in 96 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.004 g  in 96 g
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)	0.0035 g  in 96 g
MENTHOL (UNII: L7T10EIP3A)	0.0011 g  in 96 g
SQUALANE (UNII: GW89575KF9)	0.00002 g  in 96 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73333-200-01	96 g in 1 TUBE; Type 0: Not a Combination Product	02/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/14/2021

Labeler - Nutrix International, LLC. (117341868)

Establishment
Name	Address	ID/FEI	Business Operations
Nutrix international, LLC.		117341868	manufacture(73333-200) , label(73333-200) , pack(73333-200)