8d3e0dd0-b584-413b-adf3-5c2d05ab72dd

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.
Active Ingredient

ACTIVE INGREDIENT (IN EACH 10 ml)

SODIUM FLUORIDE 4.4 mg

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

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

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.
Active Ingredient (55106-9)

ACTIVE INGREDIENT (IN EACH 10 ml)

SODIUM FLUORIDE 4.4 mg

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

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

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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Advanced Ingredient Data


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