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NDC 74154-0015-04 Kiss My Face Sensitive Fluoride-Free Whitening - Citrus Mint 0.05 g/g Details

Kiss My Face Sensitive Fluoride-Free Whitening - Citrus Mint 0.05 g/g

Kiss My Face Sensitive Fluoride-Free Whitening - Citrus Mint is a DENTAL PASTE, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by Windmill Health Products, LLC. The primary component is POTASSIUM NITRATE.

Product Information

NDC	74154-0015
Product ID	74154-015_c856117d-0466-4bf6-b1d0-0b6b0602d10e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Kiss My Face Sensitive Fluoride-Free Whitening - Citrus Mint
Proprietary Name Suffix	n/a
Non-Proprietary Name	Potassium Nitrate
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE, DENTIFRICE
Route	DENTAL
Active Ingredient Strength	0.05
Active Ingredient Units	g/g
Substance Name	POTASSIUM NITRATE
Labeler Name	Windmill Health Products, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 74154-0015-04 (74154001504)

Pricing Information	N/A
NDC Package Code	74154-015-04
Billing NDC	74154001504
Package	1 TUBE in 1 CARTON (74154-015-04) / 127 g in 1 TUBE
Marketing Start Date	2022-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dfd90674-9c96-46da-9692-583dc3594d0e Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Potassium Nitrate 5.0% w/w

Purpose

Tooth desensitizer

Uses

Helps relieve sensitivity due to cold, heat, acid or sweets.

Aids in the prevention of plaque and tartar build-up.

Warnings

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

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

Apply at least a 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day or as recommended by a dentist or doctor.
Children under 6 years of age: consult a dentist or doctor.

Inactive ingredients

Sorbitol, Glycerin, Hydrated Silica, Water, Xylitol, Aloe Barbadensis Leaf Extract1, Cetraria Islandica (Iceland Moss) Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Leaf Extract, Echinacea Angustifolia Extract, Stevia Rebaudiana Extract, Natural Flavor, Mentha Piperita (Peppermint) Oil, Ammonium Glycyrrhizate (Licorice Root Extract), Xanthan Gum, Menthol, Sodium Methyl Cocoyl Taurate, Sodium Lauroyl Sarcosinate, Cellulose Gum, Chlorophyllin-Copper Complex, Potassium Sorbate

1: Organic

PRINCIPAL DISPLAY PANEL - 127 g Tube Carton

FLUORIDE FREE WHITENING TOOTHPASTE

KISS

MY

FACE®

BREATH BLASTING FRESHNESS™

SENSITIVE

PROTECTION FOR SENSITIVE TEETH & GUMS

with Tea Tree Oil, Aloe & Iceland Moss

CITRUS MINT GEL

• 100% VEGAN • TRICLOSAN & SLS FREE • BPA FREE • NO ARTIFICIAL COLORS OR FLAVORS

NET WT. 4.5 OZ

PRINCIPAL DISPLAY PANEL - 127 g Tube Carton

INGREDIENTS AND APPEARANCE

KISS MY FACE SENSITIVE FLUORIDE-FREE WHITENING - CITRUS MINT

potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74154-015
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Potassium Nitrate (UNII: RU45X2JN0Z) (Nitrate Ion - UNII:T93E9Y2844)	Potassium Nitrate	0.05 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Hydrated Silica (UNII: Y6O7T4G8P9)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
CETRARIA ISLANDICA WHOLE (UNII: BJ7YPN79A1)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
Tea Tree Oil (UNII: VIF565UC2G)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
Echinacea Angustifolia Whole (UNII: VB06AV5US8)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
PEPPERMINT OIL (UNII: AV092KU4JH)
Licorice (UNII: 61ZBX54883)
Xanthan Gum (UNII: TTV12P4NEE)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)
Sodium Lauroyl Sarcosinate (UNII: 632GS99618)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)
Potassium Sorbate (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74154-015-04	1 in 1 CARTON	02/18/2022
1		127 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	02/18/2022

Labeler - Windmill Health Products, LLC (831136267)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead		080046418	MANUFACTURE(74154-015)

Revised: 2/2022

Document Id: c856117d-0466-4bf6-b1d0-0b6b0602d10e

Set id: dfd90674-9c96-46da-9692-583dc3594d0e

Version: 1

Effective Time: 20220208