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NDC 74154-0014-04 Kiss My Face Kids Fluoride - Berry Smart 7.6 mg/g Details

Kiss My Face Kids Fluoride - Berry Smart 7.6 mg/g

Kiss My Face Kids Fluoride - Berry Smart 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 SODIUM MONOFLUOROPHOSPHATE.

Product Information

NDC	74154-0014
Product ID	74154-014_0a00e743-5e0a-4334-84e2-7dd4c07d06c2
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 Kids Fluoride - Berry Smart
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Monofluorophosphate
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE, DENTIFRICE
Route	DENTAL
Active Ingredient Strength	7.6
Active Ingredient Units	mg/g
Substance Name	SODIUM MONOFLUOROPHOSPHATE
Labeler Name	Windmill Health Products, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2024-12-31

Package

Package Images

NDC 74154-0014-04 (74154001404)

Pricing Information	N/A
NDC Package Code	74154-014-04
Billing NDC	74154001404
Package	1 TUBE in 1 CARTON (74154-014-04) / 113 g in 1 TUBE
Marketing Start Date	2022-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 610efdf8-1397-494d-9b12-72e36cdd1f01 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Monofluorophosphate 0.76% w/w

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Keep out of 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.

Directions

adults and children 6 years of age and older:

brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor.
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 6 years of age: Consult a dentist or doctor.

Inactive ingredients:

water, glycerin, hydrated silica, xylitol, vaccinium macrocarpon (cranberry) fruit powder, zinc citrate, aloe barbadensis leaf extract, melaleuca alternifolia (tea tree) leaf oil, natural flavor, stevia rebaudiana extract, cellulose gum, sorbic acid

PRINCIPAL DISPLAY PANEL - 4.0 OZ Tube Carton

ANTI-CAVITY FLUORIDE TOOTHPASTE

KISS

MY

FACE®

KIDS

CAVITY FIGHTING

SUGAR FREE

with Tea Tree Oil

& Aloe

berry smart™

VEGAN

PARABEN & BPA FREE

TRICLOSAN & SLS FREE

NO ARTIFICIAL

COLORS OR FLAVORS

NET WT. 4.0 OZ

PRINCIPAL DISPLAY PANEL - 4.0 OZ Tube Carton

INGREDIENTS AND APPEARANCE

KISS MY FACE KIDS FLUORIDE - BERRY SMART

sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74154-014
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
hydrated silica (UNII: Y6O7T4G8P9)
xylitol (UNII: VCQ006KQ1E)
cranberry (UNII: 0MVO31Q3QS)
zinc citrate (UNII: K72I3DEX9B)
aloe vera leaf (UNII: ZY81Z83H0X)
tea tree oil (UNII: VIF565UC2G)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
sorbic acid (UNII: X045WJ989B)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74154-014-04	1 in 1 CARTON	02/18/2022
1		113 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 Final	part355	02/18/2022

Labeler - Windmill Health Products, LLC (831136267)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead		080046418	MANUFACTURE(74154-014)

Revised: 2/2022

Document Id: 0a00e743-5e0a-4334-84e2-7dd4c07d06c2

Set id: 610efdf8-1397-494d-9b12-72e36cdd1f01

Version: 1

Effective Time: 20220208