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CLOSE UP Freshening Gel

Approved
Approval ID

e660b0d7-4cc5-4028-bdf5-016b85899728

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Church & Dwight Co., Inc.

DUNS: 001211952

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10237-644
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (11)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
PEG-8 STEARATEInactive
Code: 2P9L47VI5E
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 2.4 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2025

Principal Display Panel

ANITCAVITY FLOURIDE TOOTHPASTE

FRESH BREATH

Fights bad breath while gently whitening

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CINNAMON BLAST

NET WT. 4.0 OZ. (113g)

![CLOSE-UP Fresh Breath Carton](/dailymed/image.cfm?name=2172370+CLOSE- UP+Fresh+Breath+Carton.jpg&id=898669)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/11/2012

**Use:**Aids in the prevention of dental decay

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/11/2012

Active ingredients
Sodium fluoride (0.24%)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/11/2012

Purpose
Anticavity toothpaste

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/11/2012

Warnings
** Keep out of reach of children under 6 years of age**.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/11/2012

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/11/2012

Directionsdo not swallow supervise children as necessary until capable of using without supervision

adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years ask a dentist or physician

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/11/2012

Inactive ingredients sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, red 33, red 40.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/11/2012

Questions or comments? Call1-800-786-5135Monday-Friday 9am-5pm ET

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