SOLUVITA SODIUM FLUORIDE DROPS- sodium fluoride liquid

SoluVita Sodium Fluoride Drops by

Drug Labeling and Warnings

SoluVita Sodium Fluoride Drops by is a Other medication manufactured, distributed, or labeled by Patrin Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts Serving Size: 1.0 mL Servings per container: 50
	Amount Per Serving	% DV
* U.S. Recommended Daily Value not established.
Fluoride	0.5 mg	*

Other Ingredients

Purified Water, Sodium Benzoate, Ascorbic Acid , Strawberry Flavor , Sucralose, Red #33

Description

SoluVita® Sodium Fluoride Drops is a dietary supplement of fluoride to be used only under the supervision of a medical professional for patients living in areas where the drinking water fluoride level does not exceed 0.6 ppm.

See the guidelines for supplementation from the American Dental Association (ADA) and American Academy of Pediatrics (AAP) under the Dosage and Administration section.

WARNINGS

KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, call a Poison Control Center immediately.

Do not use in areas where drinking water fluoride level exceeds 0.6 ppm. Do not administer to patients less than 6 months old.

Storage

Store at controlled room temperature 20-25°C (68-77°F). Excursions permitted 15-30°C (59-86°F). After opening, store away from direct light. Close tightly after each use.

Tamper-Evident

Do not use if seal under cap is torn, broken or missing.

These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease and should be used only under the supervision of a medical professional.

Questions?

Call (800) 936 3088

Dosage and Administration

SoluVita® Sodium Fluoride Drops should be used only under the supervision of a medical professional. The ADA and AAP recommends that daily intake should not exceed these guidelines.

Daily Fluoride Supplement Dosage
Age	Fluoride ion level in drinking water (ppm)
	< 0.3 PPM	0.3-0.6 PPM	> 0.6 PPM
6 mo-3 yrs	0.25 mg F =½ mL	0	0
3 yrs-6 yrs	0.5 mg F =1 mL	0.25 mg F =½ mL	0
6 yrs-16 yrs	1 mg F =2 mL	0.5 mg F =1 mL	0

For Oral Use Only.

Do not use with dairy products.

Each bottle comes with an accompanying calibrated dropper.

SHAKE WELL BEFORE USING.

HEALTH CLAIM

Made in the USA

Patrin Pharma
Skokie, IL 60076

www.patrinpharma.com

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

39328-007-50

SoluVita®
Sodium Fluoride
Drops

0.5 mg of Fluoride Ion per mL

Sugar Free Gluten Free
Alcohol Free Lactose Free

1 2/3 fl. oz. (50 mL)

PATRIN
PHARMA

INGREDIENTS AND APPEARANCE

SOLUVITA SODIUM FLUORIDE DROPS 
sodium fluoride liquid

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:39328-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O)	Fluoride ion	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium benzoate (UNII: OJ245FE5EU)
Ascorbic acid (UNII: PQ6CK8PD0R)
STRAWBERRY (UNII: 4J2TY8Y81V)
Sucralose (UNII: 96K6UQ3ZD4)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:39328-007-50	1 in 1 CARTON
1		50 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		04/09/2025

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
flavor

Labeler - Patrin Pharma (806841677)