Label: MAESA - HEY HUMAN- clean mint rush paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 73333-200-01 - Packager: Nutrix International, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 19, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
- Questions or Comments
- Package, Label
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INGREDIENTS AND APPEARANCE
MAESA - HEY HUMAN
clean mint rush paste, dentifriceProduct 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)
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