SPL v8
SPL
SPL Set ID 8d3e0dd0-b584-413b-adf3-5c2d05ab72dd
Route
ORAL
Published
Effective Date 2023-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (4.4 mg)
Inactive Ingredients
Sodium Phosphate, Monobasic, Monohydrate Sodium Benzoate Saccharin Sodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1989-01-01
Description

ACTIVE INGREDIENT (IN EACH 10 ml) SODIUM FLUORIDE 4.4 mg

Medication Information

Warnings and Precautions

Warnings

  • When using this product, do not swallow unless to do so by a dentist or physician.
  • If more solution is accidentally swallowed than used for rinsing, get medical help or
  • contact a Poison Control Center immediately.
Indications and Usage

Use

Aids in the prevention of dental decay

Dosage and Administration

DIRECTIONS: Use As Directed

ADULTS AND CHILDREN 6 YEARS AND OLDER

USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE.  VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING.  INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING.

CHILDREN UNDER 6

CONSULT A DENTIST OR PHYSICIAN

Description

ACTIVE INGREDIENT (IN EACH 10 ml) SODIUM FLUORIDE 4.4 mg

Section 34072-9

OTHER INFORMATION

  • Store at room temperature.
Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

Inactive Ingredients : Deionized water, monosodium

phosphate, phosphoric acid, sodium benzoate, sodium

saccharin, artificial coloring, artificial flavoring.

Section 53413-1

QUESTIONS? COMMENTS?

CALL 1-479-787-5168 M-F 9 am TO 5pm CST

Section 55105-1

Purpose

Anticavity

Section 55106-9

ACTIVE INGREDIENT (IN EACH 10 ml)

SODIUM FLUORIDE 4.4 mg

Package Label

ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE 0.044% SODIUM FLUORIDE IN AN ACIDULATED PHOSPHATE TOPICAL SOLUTION.  MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE AR (479) 787-5168.  WWW.MASSCODENTAL.NET

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Structured Label Content

Indications and Usage (34067-9)

Use

Aids in the prevention of dental decay

Dosage and Administration (34068-7)

DIRECTIONS: Use As Directed

ADULTS AND CHILDREN 6 YEARS AND OLDER

USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE.  VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING.  INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING.

CHILDREN UNDER 6

CONSULT A DENTIST OR PHYSICIAN

Warnings and Precautions (34071-1)

Warnings

  • When using this product, do not swallow unless to do so by a dentist or physician.
  • If more solution is accidentally swallowed than used for rinsing, get medical help or
  • contact a Poison Control Center immediately.
Section 34072-9 (34072-9)

OTHER INFORMATION

  • Store at room temperature.
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

Inactive Ingredients : Deionized water, monosodium

phosphate, phosphoric acid, sodium benzoate, sodium

saccharin, artificial coloring, artificial flavoring.

Section 53413-1 (53413-1)

QUESTIONS? COMMENTS?

CALL 1-479-787-5168 M-F 9 am TO 5pm CST

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

ACTIVE INGREDIENT (IN EACH 10 ml)

SODIUM FLUORIDE 4.4 mg

Package Label (PACKAGE LABEL)

ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE 0.044% SODIUM FLUORIDE IN AN ACIDULATED PHOSPHATE TOPICAL SOLUTION.  MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE AR (479) 787-5168.  WWW.MASSCODENTAL.NET

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.967053 · Updated: 2026-03-14T23:02:08.105317