DR.EL CHARCOR PARTY TOOTH- silica, sodium monofluorophosphate, tocopheryl acetate, hydrated silica paste, dentifrice

Dr.EL CHARCOR PARTY TOOTH by

Drug Labeling and Warnings

Dr.EL CHARCOR PARTY TOOTH by is a Otc medication manufactured, distributed, or labeled by Dr. EL CO., LTD., Green Wonil Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silica
Sodium Monofluorophosphate
Tocopheryl Acetate

Hydrated Silica

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Supervise children as necessary until capable of using without Supervision.

Adults and children 6 years of age and older: Bursh 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 swallpwing)

WARNINGS

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

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

INACTIVE INGREDIENT

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.EL CHARCOR PARTY TOOTH 
silica, sodium monofluorophosphate, tocopheryl acetate, hydrated silica paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72440-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9) (HYDRATED SILICA - UNII:Y6O7T4G8P9)	HYDRATED SILICA	10 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.09 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	5 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.38 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72440-100-01	120 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2019

Labeler - Dr. EL CO., LTD. (694771074)

Registrant - Dr. EL CO., LTD. (694771074)

Establishment
Name	Address	ID/FEI	Business Operations
Green Wonil Co., Ltd		688442099	manufacture(72440-100)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. EL CO., LTD.		694771074	label(72440-100)