KUNDAL PURE REFRESHING WHITENING TOOTH (SPEARMINT)- hydrogen peroxide, silicon dioxide paste 
THESKINFACTORY Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Hydrogen Peroxide, Konasil (Fumed Silica = Silicon Dioxide)

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

for dental care

KEEP OUT OF REACH OF THE CHILDREN

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.

Do not swallow.

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

For dental use only

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KUNDAL PURE REFRESHING WHITENING TOOTH (SPEARMINT) 
hydrogen peroxide, silicon dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74773-0041
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.14 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74773-0041-12 in 1 BOX09/01/2020
1150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2020
Labeler - THESKINFACTORY Co., Ltd. (694804099)
Registrant - THESKINFACTORY Co., Ltd. (694804099)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(74773-0041)
Establishment
NameAddressID/FEIBusiness Operations
THESKINFACTORY Co., Ltd.694804099label(74773-0041)

Revised: 9/2020
Document Id: af551050-2068-79a9-e053-2a95a90a9854
Set id: af534ea8-b549-57cd-e053-2a95a90afc10
Version: 2
Effective Time: 20200915
 
THESKINFACTORY Co., Ltd.