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NDC 48878-3150-04 Clinpro Tooth Creme 0.95 mg/g Details

Clinpro Tooth Creme 0.95 mg/g

Clinpro Tooth Creme is a ORAL PASTE, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by 3M ESPE Dental Products. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 48878-3150-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	48878-3150
Product ID	48878-3150_47362d79-d214-4468-a858-c78916e91132
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	Clinpro Tooth Creme
Proprietary Name Suffix	n/a
Non-Proprietary Name	sodium fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE, DENTIFRICE
Route	ORAL
Active Ingredient Strength	0.95
Active Ingredient Units	mg/g
Substance Name	SODIUM FLUORIDE
Labeler Name	3M ESPE Dental Products
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 48878-3150-04 (48878315004)

Pricing Information	N/A
NDC Package Code	48878-3150-4
Billing NDC	48878315004
Package	1 TUBE in 1 BOX (48878-3150-4) / 113 g in 1 TUBE
Marketing Start Date	2013-07-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 786c6184-6bc8-4376-9ce2-3e35af193210 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium fluoride 0.21% (0.12% w/v fluoride ion)

Purpose

Anticavity Toothpaste

Use

helps protect teeth and roots against cavities

Warnings

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
do not swallow
to minimize swallowing, use a pea-sized amount in children under 6
supervise children's brushing until good habits are established
children under 2 years, ask your dentist

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, polyethylene-polypropylene glycol, flavor, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, carboxymethyl cellulose, sodium saccharin, tri-calcium phoshate

Questions? 1-800-634-2249

Principal Display Panel

NDC 48878-3150-4

3M ESPE

Clinpro™ Tooth Crème

Vanilla Mint

0.21% Sodium Flouride

Anti-Cavity Toothpaste

Contents: 1 Tube NET WT 4 oz (113 g)

INGREDIENTS AND APPEARANCE

CLINPRO TOOTH CREME

sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48878-3150
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.950 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Vanilla Mint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:48878-3150-4	1 in 1 BOX	07/18/2013
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	07/18/2013

Labeler - 3M ESPE Dental Products (801390852)

Revised: 7/2020

Document Id: 47362d79-d214-4468-a858-c78916e91132

Set id: 786c6184-6bc8-4376-9ce2-3e35af193210

Version: 5

Effective Time: 20200708