Label: MY EARTHDAY ALPHA CARE PLUS- hydrated silica, calcium glycerophosphate, sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 82368-001-01, 82368-001-02 - Packager: J&P INTERNATIONAL CO., LTD
- 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 November 23, 2021
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- Official Label (Printer Friendly)
- active ingredient
- KEEP OUT OF REACH OF CHILDREN
- Purpose
- Uses
- Warnings
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Directions
Adults and children 6 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 under 12 years old
Instruct in good brushing and rinsing habits (to minimize swallowing)
Children under 6 years old
Do not use unless directed by a dentist or a physician
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Inactive Ingredients
Hydroxyapatite, Pyridoxine Hydrochloride, Tocopherol Acetate, Xanthangum, Sorbitol, Glycerin, Sodium Cocoyl Glutamate, Citrus Paradisi (Grapefruit) Seed Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Chamomilla Recutita (Matricaria) Flower, Eucalyptus Globulus Leaf Extract, Xylitol, Fragrance, Mentha Spicata Herb Oil
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INGREDIENTS AND APPEARANCE
MY EARTHDAY ALPHA CARE PLUS
hydrated silica, calcium glycerophosphate, sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82368-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.37 g in 100 g Inactive Ingredients Ingredient Name Strength HYDRATED SILICA (UNII: Y6O7T4G8P9) 10 g in 100 g CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C) 0.13 g in 100 g TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) CITRUS PARADISI SEED (UNII: 12F08874Y7) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SAGE (UNII: 065C5D077J) CHAMOMILE (UNII: FGL3685T2X) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) XYLITOL (UNII: VCQ006KQ1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82368-001-02 1 in 1 CARTON 11/23/2021 1 NDC:82368-001-01 60 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 11/23/2021 Labeler - J&P INTERNATIONAL CO., LTD (694319881) Registrant - J&P INTERNATIONAL CO., LTD (694319881) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD. 557810721 manufacture(82368-001)
