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Ortho Guard

Package insert / prescribing information
Generic name: sodium fluoride
Dosage form: gel, dentifrice
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT (IN EACH 10 ml)

SODIUM FLUORIDE 4.4 mg

Purpose

Anticavity

Inactive Ingredients: Deionized water, monosodium

phosphate, phosphoric acid, sodium benzoate, sodium

saccharin, artificial coloring, artificial flavoring.

Use

Aids in the prevention of dental decay

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.

KEEP OUT OF REACH OF CHILDREN

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

OTHER INFORMATION

  • Store at room temperature.

QUESTIONS? COMMENTS?

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

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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Ortho Guard
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63783-400
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 4.4 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM BENZOATE
SACCHARIN SODIUM
Product Characteristics
Color Score
Shape Size
Flavor MINT (ICY COOL MINT) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:63783-400-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/01/1989
Ortho Guard
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63783-401
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 4.4 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM BENZOATE
SACCHARIN SODIUM
Product Characteristics
Color Score
Shape Size
Flavor GRAPE (GRAPE) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:63783-401-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/01/1989
Ortho Guard
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63783-402
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 4.4 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM BENZOATE
SACCHARIN SODIUM
Product Characteristics
Color Score
Shape Size
Flavor ORANGE (ORANGE) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:63783-402-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/01/1989
Ortho Guard
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63783-403
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 4.4 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM BENZOATE
SACCHARIN SODIUM
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY (STRAWBERRY) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:63783-403-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Establishment
Name Address ID/FEI Operations
Massco Dental A Division of Dunagin Pharmaceuticals 008081858 manufacture(63783-400, 63783-401, 63783-402, 63783-403)
Massco Dental A Division of Dunagin Pharmaceuticals