KISS MY FACE ENAMEL EXTRA- potassium nitrate, sodium fluoride gel, dentifrice 
Kiss My Face, LLC

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.

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Kiss My Face Enamel Extra Cool Mint Gel Toothpaste

Drug Facts

Active ingredient

Potassium Nitrate 5.0% w/w

Sodium Fluoride 0.243% w/w

Purpose

Antihypersensitivity

Anticavity

Uses

Warnings

  • Keep out of reach of children under 6 years of age
  • If you accidentally swallow more than used for brushing, contact a Poison Control Center or seek professional assistance immediately.

Directions

Other information

You may report a serious adverse event from using this product to Kiss My Face LLC, 144 Main St, Gardiner NY 12525.

Inactive ingredients Glycerin, Water, Sorbitol, Hydrated Silica, Xylitol, Calcium Glycerophosphate, Aloe Barbadensis (Aloe Vera) Leaf Extract*, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Leaf Extract, Stevia Rebaudiana Extract, Natural Flavor, Mentha Piperita (Peppermint) Oil, Menthol, Ammonium Glycyrrhizate (Licorice) Root Extract, Xanthan Gum, Cellulose Gum, Sodium Methyl Cocoyl Taurate, Sodium Lauroyl Saracosinate, Chlorophyllin-Copper Complex, Potassium Sorbate

Dist: Kiss My Face LLC

Gardiner, NY 12525 USA

KISS MY FACE

BREATH BLASTING FRESHNESS

ENAMEL EXTRA

ANTICAVITY FLUORIDE Toothpaste with Xylitol

Cool Mint Gel

HELPS REHARDEN ENAMEL • WHITENS • REDUCES SENSITIVITY

antioxidant defenders™: tea tree oil • olive leaf extract

Net Wt. 4.5 oz (127.6 g)

KMF 65364-403 Enamel Xtra Anticavity Toothpaste Cool Mint

KISS MY FACE  ENAMEL EXTRA
potassium nitrate, sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-403
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)  
SORBITOL (UNII: 506T60A25R)  
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)  
TEA TREE OIL (UNII: VIF565UC2G)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MENTHOL (UNII: L7T10EIP3A)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65364-403-271 in 1 CARTON04/01/2015
1127.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/01/2015
Labeler - Kiss My Face, LLC (041794279)
Registrant - Lornamead Inc. (078584069)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(65364-403)

Revised: 2/2019
Document Id: 825406a8-8117-9160-e053-2991aa0a7449
Set id: 825406a8-8123-9160-e053-2991aa0a7449
Version: 1
Effective Time: 20190220
 
Kiss My Face, LLC