MY EARTHDAY ALPHA CARE PLUS- hydrated silica, calcium glycerophosphate, sodium monofluorophosphate paste, dentifrice

My Earthday Alpha Care Plus by

Drug Labeling and Warnings

My Earthday Alpha Care Plus by is a Otc medication manufactured, distributed, or labeled by J&P INTERNATIONAL CO., LTD, DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredient

Hydrated Silica

Calcium Glycerophosphate

Sodium Monofluorophosphate

KEEP OUT OF REACH OF CHILDREN

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

Purpose

Anticavity

Uses

Aids in the cleanness of teeth

Warnings

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MY EARTHDAY ALPHA CARE PLUS 
hydrated silica, calcium glycerophosphate, sodium monofluorophosphate paste, dentifrice

Product 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)