KUNDAL PURE REFRESHING WHITENING TOOTH (SPEARMINT)- hydrogen peroxide, silicon dioxide paste

KUNDAL Pure Refreshing Whitening Tooth (Spearmint) by

Drug Labeling and Warnings

KUNDAL Pure Refreshing Whitening Tooth (Spearmint) by is a Otc medication manufactured, distributed, or labeled by THESKINFACTORY Co., Ltd., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrogen Peroxide, Konasil (Fumed Silica = Silicon Dioxide)

INACTIVE INGREDIENT

Glycerin, PEG-32, Cellulose Gum, Xanthan Gum, Disodium Pyrophosphate, Salvia Officinalis (Sage) Leaf Extract, Eucalyptus Globulus Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extact, Camellia Sinensis Leaf Extract, Disodium EDTA, Xylitol, Stevioside, Sodium Benzotate, Sodium Cocoyl Glumate, Menthol, Cooling Fragrance, Spearmint Oil, Spearmint Flavor, Water

PURPOSE

for dental care

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

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 doctor.

Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

WARNINGS

Do not swallow.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

1

INGREDIENTS AND APPEARANCE

KUNDAL PURE REFRESHING WHITENING TOOTH (SPEARMINT) 
hydrogen peroxide, silicon dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74773-0041
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.14 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74773-0041-1	2 in 1 BOX	09/01/2020
1		150 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
unapproved drug other		09/01/2020

Labeler - THESKINFACTORY Co., Ltd. (694804099)

Registrant - THESKINFACTORY Co., Ltd. (694804099)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(74773-0041)

Establishment
Name	Address	ID/FEI	Business Operations
THESKINFACTORY Co., Ltd.		694804099	label(74773-0041)