Label: HELLO ACTIVATED CHARCOAL PLUS MATCHA GREEN TEA EPIC WHITENING FLUORIDE- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 55882-6105-1
- Packager: Hello Products 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.
Updated June 16, 2020
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
adults and children 2 years of age 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 use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician
sorbitol, hydrated silica, vegetable glycerin, xylitol, purified water, charcoal powder, flavor, xanthan gum, titanium dioxide, camellia sinensis (matcha) leaf extract, cocos nucifera (coconut) oil, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract1.
- certified organic
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 113 g Tube Box
activated charcoal +
matcha green tea
farm grown mint
noticeably whiter teeth
no peroxide. no artificial sweeteners.
no dyes. no SLS/sulfates. no brainer.
NET WT 4.0 OZ (113g)
INGREDIENTS AND APPEARANCE
HELLO ACTIVATED CHARCOAL PLUS MATCHA GREEN TEA EPIC WHITENING FLUORIDE
sodium monofluorophosphate paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55882-6105 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) fluoride ion 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Hydrated silica (UNII: Y6O7T4G8P9) Water (UNII: 059QF0KO0R) Xylitol (UNII: VCQ006KQ1E) Glycerin (UNII: PDC6A3C0OX) Activated Charcoal (UNII: 2P3VWU3H10) Xanthan Gum (UNII: TTV12P4NEE) Titanium dioxide (UNII: 15FIX9V2JP) Coconut Oil (UNII: Q9L0O73W7L) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG) Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876) Green Tea Leaf (UNII: W2ZU1RY8B0) Product Characteristics Color BLACK Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55882-6105-1 1 in 1 BOX 12/01/2019 1 113 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 12/01/2019 Labeler - Hello Products LLC (040714890) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 MANUFACTURE(55882-6105)